Hernia Repair Sequelae

Volker Schumpelick Robert J. Fitzgibbons (Eds.) Hernia Repair Sequelae

Volker Schumpelick Robert J. Fitzgibbons (Eds.)

Hernia Repair Sequelae In Collaboration with Joachim Conze

With 236 Figures and 97 Tables

1 23

Prof. Dr. Volker Schumpelick

Prof. Dr. Robert J. Fitzgibbons

Chirurgische Klinik Universitätsklinikum Aachen Pauwelsstraße 30 52074 Aachen Germany e-mail: [email protected]

Department of Surgery Creighton University 601 North 30th Street Suite 3740 Omaha, NE 68131 USA e-mail: [email protected]

ISBN 978-3-642-04552-3 Springer-Verlag Berlin Heidelberg New York Bibliografische Information der Deutschen Bibliothek The Deutsche Bibliothek lists this publication in Deutsche Nationalbibliographie; detailed bibliographic data is available in the internet at http://dnb.ddb.de. This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permission for use must always be obtained from Springer-Verlag. Violations are liable to prosecution under the German Copyright Law. Springer Medizin Springer-Verlag GmbH ein Unternehmen von Springer Science+Business Media springer.de © Springer-Verlag Berlin Heidelberg 2010 The use of general descriptive names, registered names, trademarks, etc. in this publications does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. Product liability: The publishers cannot guarantee the accuracy of any information about dosage and application contained in this book. In every individual case the user must check such information by consulting the relevant literature.

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5135 – 5 4 3 2 1 0

V

Preface At the last Suvretta meeting in 2006 on recurrent hernia prevention and treatment, we demonstrated that with the wide range of available techniques, materials, and meshes at our disposal today, an experienced hernia surgeon will be able to prevent or at least treat a recurrent hernia. But whereas recurrences can be treated successfully in most cases, some other hernia repair sequelae can result in severe, sometimes untreatable problems, e.g. pain, infection, adhesion, or infertility. That was the reason to focus the 5th Suvretta meeting in 2008 on hernia repair sequelae. We are convinced that such sequelae can be a more serious problem for the patient than the mostly treatable recurrent hernia. Therefore, it was appropriate to focus the 5th Suvretta meeting on these longterm problems. During a four-day meeting, we discussed all technical aspects of the various operations and materials to generate a consensus concerning the best techniques and meshes. We explored methods to improve surgical techniques to look into the multifactorial causes of post hernia repair sequelae. In the seclusion of the Swiss plateau valley we had a perfect setting to discuss these important hernia repair problems in detail with the top hernia specialists in the world. With this book, the results of this exceptional 5th Suvretta meeting have been made accessible for every surgeon who is interested in hernia surgery and its sequelae. V. Schumpelick

VII

List of First Authors Alfieri, S.

Bachman, S. L.

Champault, G. G.

Department of Digestive Surgery Catholic University of Sacred Heart Largo Agostino Gemelli 8 00168 Rome Italy [email protected]

University of Missouri Department of Surgery Missouri Hernia Institute University of Missouri–Columbia 414 McHaney Hall Columbia, MO 65211 USA

Paris University XIII – Medical School »Léonard de Vinci« Department of Digestive Surgery University Hospital Jean Verdier Avenue du 14 Juillet 93140 Bondy France [email protected]

Amid, P. K. Department of Surgery David Geffen School of Medicine at UCLA Lichtenstein Hernia Institute at UCLA 1260 15th Street, Suite 1200 Santa Monica, CA 90404 USA [email protected]

Bellows, C. Associate Professor of Surgery Chief, General Surgery Director of Surgical Research General and Laparoscopic Surgery Tulane University New Orleans, LA USA

Chowbey, P. K. Minimal Access, Metabolic and Bariatric Surgery Centre Sir Ganga Ram Hospital Room No. 200 (IInd floor) New Delhi 110060 India [email protected]

Berger, D. Arlt, G. D. Department of Surgery Park-Klinik Weissensee Schönstrasse 80 13086 Berlin Germany [email protected]

Department of Surgery Stadtklinik Balgerstrasse 50 76532 Baden-Baden Germany [email protected]

Conze, J. Department of Surgery University Hospital RWTH Pauwelsstrasse 30 52074 Aachen Germany [email protected]

Binnebösel, M. Aufenacker, T. J. Department of Surgery (C22) Canisius Wilhelmina Ziekenhuis (CWZ) Postbus 9015 6500 GS Nijmegen The Netherlands [email protected]

Aydede, H. Associate Professor of Surgery Celal Bayar University Medical Faculty Department of Surgery Manisa Turkey [email protected]

Department of Surgery RWTH Aachen University Hospital Pauwelsstrasse 30 52074 Aachen Germany [email protected]

Demirer, S. D. Ankara University School of Medicine Department of Surgery Ankara Turkey [email protected]

Bringman, S. Clintec, Karolinska Institutet Stockholm, Sweden Departments of Surgery, Södertälje Hospital Södertälje Sweden [email protected]

Deysine, M. Professor of Surgery Winthrop University Hospital Mineola, NY USA [email protected]

VIII

List of First Authors

Diaz, J. J., Jr.

Flament, J. B.

Hegarty, D.

Division of Trauma and Surgical Critical Care Department of Surgery Vanderbilt University Medical Center Nashville, TN USA [email protected]

Department of Surgery Faculty of Medicine University of Reims ChampagneArdenne General Surgery Service Hôpital Robert Debré Rue Serge Kochman 51100 Reims France [email protected]

Department of Anaesthesia, Intensive Care & Pain Medicine Cork University Hospital Cork Ireland [email protected]

Dilek, O. N. Professor of General Surgery School of Medicine Kocatepe University PK:70 03100 Afyonkarahisar Turkey [email protected]

Falagas, M. E. Department of Medicine, Henry Dunant Hospital, Athens, Greece Department of Medicine, Tufts University School of Medicine, Boston, MA, USA Alfa Institute of Biomedical Sciences (AIBS) 9 Neapoleos Street, 151 23 Marousi Athens, Greece [email protected]

Franz, M. G. Associate Professor of Surgery Chief, Minimally Invasive Surgery University of Michigan Department of Surgery 2214F Taubman Center 1500 East Medical Center Drive Ann Arbor, MI 48109 USA [email protected]

Goldenberg, A. Associate Professor Department of Surgery Federal University of Sao Paulo Brazil [email protected]

Gryska, P. vR. Fawole, A. S. Department of Academic Surgery St. James’s University Hospital Beckett Street Leeds LS9 7TF UK [email protected]

Tufts University School of Medicine Boston, MA Department of Surgery Newton-Wellesley Hospital Suite 365, 2000 Washington Street Newton, MA 0246 USA [email protected]

Hansson, B. Department of Surgery Canisius Wilhelmina Hospital Nijmegen The Netherlands

Honigsberg, E. Mount Sinai Medical Center 1010 5th Avenue New York, NY 10028 USA

Hopf, H. W. Department of Anesthesiology, University of Utah Medical Director, Urban Central Region Wound Care Services LDS Hospital 8th Avenue and C Street Salt Lake City, UT 84132 USA [email protected]

Jansen, M. Department of Surgery University Hospital RWTH Aachen Pauwelsstrasse 30 52074 Aachen Germany [email protected]

Jansen, P. L. Department of Surgery University Hospital RWTH Aachen Pauwelsstrasse 30 52074 Aachen Germany [email protected]

IX List of First Authors

Junge, K.

Kolbe, T.

Montgomery, A.

Department of Surgery Technical University of Aachen Pauwelsstrasse 30, 52057 Aachen Germany [email protected]

Biomodels Austria, University of Veterinary Medicine Veterinärplatz 1 1210 Vienna Austria [email protected]

Department of Surgery Malmö University Hospital 20502 Malmö Sweden [email protected]

Kaemmer, D.

Kukleta, J. F.

Department of Surgery RWTH Aachen Pauwelsstr. 30 52074 Aachen Germany [email protected]

Klinik Im Park Seestrasse 220 8027 Zurich Switzerland [email protected]

Morales-Conde, S.

Muschaweck, U. Kurzer, M.

Kavvadias, T. Department of Obstetrics and Gynaecology Lucerne Cantonal Hospital Lucerne Switzerland

Kehlet, H. Section for Surgical Pathophysiology 4074 Rigshospitalet Copenhagen University Blegdamsvej 9 2100 Copenhagen Denmark [email protected]

Klinge, U. Institute for Applied Medical Engineering Helmholtz Institute for Applied Medical Technology RWTH Aachen University Pauwelsstraße 20-30 52074 Aachen Germany [email protected]

University Hospital Virgen del Rocío. Betis-65, 1º 41010 Sevilla Spain [email protected]

British Hernia Centre 87 Watford Way London NW4 4RS UK [email protected]

Hernienzentrum Dr. Muschaweck – München Arabellastrasse 5 81925 Munich Germany [email protected]

Lammers, B. J.

Neumayer, L.

Department for Colorectal and Hernia Surgery Lukaskrankenhaus Neuss Neuss Germany [email protected]

Professor of Surgery Department of Surgery University of Utah Salt Lake City VA Healthcare System 1950 Circle of Hope Room 6540 Salt Lake City, UT 84132 USA [email protected]

Matthews, B. D. Chief, Section of Minimally Invasive Surgery Department of Surgery Washington University School of Medicine 660 S. Euclid Ave., Campus Box 8109 St. Louis, MO 63110 USA [email protected]

Nordin, P. Head of the Swedish Hernia Register Department of Surgery Östersund Hospital 831 83 Östersund Sweden [email protected]

Otto, J. Miserez, M. Department of Abdominal Surgery University Hospitals Herestraat 49 3000 Leuven Belgium [email protected]

Department of Surgery University Hospital RWTH Aachen Pauwelsstrasse 30 52074 Aachen Germany [email protected]

X

List of First Authors

Page, B. P.

Schug-Paß, C.

Stroh, C.

University Department of Surgery Western Infirmary Glasgow G11 6NT Scotland [email protected]

Department of Surgery Center for Minimally Invasive Surgery Vivantes Hospital Spandau Neue Bergstrasse 6 13585 Berlin Germany [email protected]

Department of General, Abdominal and Paediatric Surgery Municipal Hospital (Teaching Hospital of the Friedrich-Schiller University at Jena, Germany) Strasse des Friedens 122 07548 Gera Germany [email protected]

Pascual, G. Department of Medical Specialities Alcalá University Networking Research Centre on Bioengineering, Biomaterials and Nanomedicine (CIBER-BNN) Madrid Spain

Peiper, C. Surgical Clinic Evangelisches Krankenhaus Werler Strasse 110 58455 Hamm Germany [email protected]

Penkert, G. Friederikenstift Hannover Department of Neurosurgery Humboldtstrasse 5 30169 Hannover Germany [email protected]

Read, R. C. Emeritus Professor of Surgery 304 Potomac Street Rockville, MD 20850 USA [email protected]

Schippers, E. Surgical Clinic Department of General and Visceral Surgery Juliusspital Juliuspromenade 19 97070 Würzburg Germany [email protected]

Schumpelick, V. Department of Surgery University Hospital RWTH Pauwelsstrasse 30 52074 Aachen Germany [email protected]

Simons, M. P. Department of Surgery Onze Lieve Vrouwe Gasthuis Postbus 95500 1090 HM Amsterdam The Netherlands [email protected]

Smeds, S. The Sergel Clinic Department of Clinical and Experimental Medicine Faculty of Health Sciences University Hospital Linköping University 58185 Linköping Sweden [email protected]

Stanton-Hicks, M. Vice Chairman, Anesthesiology Institute Consulting Staff, CCF Shaker Children’s Pain Rehabilitation Cleveland Clinic Pain Management Department 9500 Euclid Avenue – C-25 Cleveland, OH 44195 USA [email protected]

Stumpf, M. Department of Surgery RWTH Aachen Pauwelsstrasse 30 52074 Aachen Germany michale.stumpf@ klinikum-pforzheim.de

van der Kolk, B. M. Department of Surgery, Division of Abdominal Surgery Radboud University Nijmegen Medical Center Nijmegen The Netherlands

Witkowski, P. Department of Surgery Division of Abdominal Organ Transplantation Columbia University 177 Fort Washington Ave, 7HS, Room 200C New York, NY 10032 USA [email protected]

XI

Contents 15

I Risk for the Spermatic Cord 16 17 1 2

3

4 5 6 7

8

9 10

Are There Adverse Effects of Herniorrhaphy Techniques on Testicular Perfusion? . . . . . . . . . . 3 The Effects of Mesh Bioprosthesis on the Spermatic Cord Structures in a Rat Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Damage to the Spermatic Cord by the Lichtenstein Procedure in a Pig Model– Preliminary Results . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Influence of Prosthetic Implants on Male Fertility in Rabbits and Rats . . . . . . . . . . . . . . . . . 29 The Effects of a Mesh Bioprosthesis on the Spermatic Cord Structures . . . . . . . . . . . . . . 39 Influence of Prosthetic Implants on Male Fertility in Rats . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 What Can We Do To Decrease the Risk of Vas Deferens Injury due to Inguinal Hernioplasty? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 The Long-Term Effect on Testicular Function of a Mesh Bioprosthesis Used for Inguinal Hernia Repair . . . . . . . . . . . . . . . . . . . . . . 57 Reoperation Following Lichtenstein Repair: What Do Vas and Nerves Look Like? . . . . . . . . . 65 Damage to the Spermatic Cord from Groin Herniorrhaphy: A Review . . . . . . . . . . . . . . 71

18

19

III 20

21 22

23

24

II

Risk for Infection 25

11 12

13 14

Mesh Infection Following Hernia Repair: A Frequent Problem? . . . . . . . . . . . . . . . . . . . . . . . 79 Patient Factors as a Major Determinant of Wound Outcome and Infection After Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Mesh-Related Infections After Hernia Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Human Acellular Dermal Matrix for Ventral Hernia Repair in the Compromised Surgical Field . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .103

Fate of the Inguinal Hernia Following Removal of Infected Prosthetic Mesh . . . . . . .113 Mesh Infection–Therapeutic Options . . . . . . .119 Does Antibiotic Prophylaxis Prevent the Occurrence of Wound Infection After Groin Hernia Surgery? . . . . . . . . . . . . . . . . . . . . . . . . . . . .125 Infection Control in a Hernia Clinic: 24-Year Results of Aseptic and Antiseptic Measure Implementation in 4,620 »Clean Cases« Based on Up-To-Date Microbiological Research . . . . . . . . . . . . . . . . . . . . . . . .135 Components Separation Technique: Pros and Cons . . . . . . . . . . . . . . . . . . . . . . . . . . . . .143

26 27

28 29

Risk for Pain

Self-Assessment of Discomfort and Pain after Inguinal Hernia Repair: A Reflection of Both Individual Pain Propensity and Surgical Strategy . . . . . . . . . . . . . . . . . . . . . . . . . . .155 Chronic Pain After Inguinal Hernia Repair . . .163 What Do We Know About the Pathophysiology and Pathology of Neuropathic Pain? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .169 Surgical Trauma of Nerves–Causes of Neuropathic Pain, Classification, and Options in Surgical Therapy . . . . . . . . . . . . . . . .177 Risks for Pain–Neuropathic Pain: How Should We Handle the Nerves? . . . . . . . .185 What To Consider as Clinicians About Chronic Postoperative Pain and Inguinal Herniorrhaphy . . . . . . . . . . . . . . . . . . . . . . . . . . . . .191 Risk Factors for Chronic Pain After Groin Hernia Surgery . . . . . . . . . . . . . . . . . . . . . .199 Ischemic Inflammatory Response Syndrome as an Alternative Explanation for Postherniorrhaphy Pain . . . . . . . . . . . . . . . . .207 Postoperative CRPS in Inguinal Hernia Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .213 Chronic Pain After Open Mesh Repair of Incisional Hernia . . . . . . . . . . . . . . . . . . . . . . . .221

XII

30 31 32

33

34

35

36

37

38

39

40 41

Contents

Clinical Results After Open Mesh Repair . . . .227 Acute and Chronic Pain After Laparoscopic Incisional Hernia Repair . . . . . . . . . . . . . . . . . . . .233 Effect of Nerve Identification on the Rate of Postoperative Chronic Pain Following Inguinal Hernia Surgery . . . . . . . . . . . . . . . . . . . .239 Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair: A Report from the SMIL Study Group . . . . . . .245 Recurrence or Complication: The Lesser of Two Evils? A Review of Patient-Reported Outcomes from the VA Hernia Trial . . . . . . . . .251 Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis Outweighs That of Technique . . . . . . . . . . . . . .257 The Effect of Polypropylene Mesh on the Ilioinguinal Nerve in Open Mesh Repair of Groin Hernia . . . . . . . . . . . . . . . . . . . . .265 Lightweight Macroporous Mesh vs. Standard Polypropylene Mesh in Lichtenstein Hernioplasty . . . . . . . . . . . . . . . . . .275 Does the Choice of Prosthetic Mesh Type Make a Difference in Postherniorrhaphy Groin Pain? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .279 New Understanding of the Causes and Surgical Treatment of Postherniorrhaphy Inguinodynia and Orchialgia . . . . . . . . . . . . . . .287 Surgery for Chronic Inguinal Pain: Neurectomy, Mesh Explantation, or Both? . . . 293 Results of Tailored Therapy for Patients with Chronic Inguinal Pain . . . . . . . . . . . . . . . . .299

47 48

49 50 51 52

V

53

54 55 56

57 58 59

IV 42

43 44 45

46

Risk for Adhesion

Adhesion as a Chronic Inflammatory Problem? Risk for Adhesions, Migration, and Erosions? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .305 Biological Tissue Graft: Present Status . . . . . .317 IPOM Results of 344 Consecutive Patients with a PVDF-Derived Prosthesis . . . . . . . . . . . . . 323 Pooled Data Analysis of Laparoscopic vs. Open Ventral Hernia Repair: 14 Years of Patient Data Accrual . . . . . . . . . . . . . . . . . . . . . . .331 Tissue Ingrowth, Adhesion, and Mesh Contraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .345

Effect of Different Mesh Materials on Adhesion Formation . . . . . . . . . . . . . . . . . . . . . . .353 Tissue Ingrowth and Laparoscopic Ventral Hernia Mesh Materials: An Updated Review of the Literature . . . . . . . . . . . . . . . . . . . .365 Porosity and Adhesion in an IPOM Model . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .375 Benefit of Lightweight and/or Titanium Meshes? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .381 ePTFE Prostheses and Modifications . . . . . . . .393 The Role of Stem Cells in Abdominal Wall Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .401

Risk for Migration and Erosion

Safety and Durability of Prosthetic Repair of the Hiatal Hernia: Lessons Learned from a 15-Year Experience . . . . . . . . . . . . . . . . . . . . . . .413 Mesh Migration into the Esophageal Wall After Mesh Hiatoplasty . . . . . . . . . . . . . . . .421 Complications After Gastric Banding– Results in Germany . . . . . . . . . . . . . . . . . . . . . . . .429 Alloplastic Implants for the Treatment of Stress Urinary Incontinence and Pelvic Organ Prolapse . . . . . . . . . . . . . . . . . . . . . . . . . . . .439 Prophylactic IPOM Mesh To Prevent Parastomal Hernias . . . . . . . . . . . . . . . . . . . . . . . .445 Laparoscopic Parastomal Hernia Repair: Pitfalls and Complications . . . . . . . . . . . . . . . . . .451 Concept of Visible Mesh and Possibilities for Analysis of Mesh Migration and Shrinkage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .457

VI Strategy to Improve Results 60 61

Who Has the Major Role in Hernia Surgery: The Surgeon or the Material? . . . . . . . . . . . . . . .463 Two Controversial Concepts: Standard Procedure in a Standard Patient Versus Tailored Surgery with Procedures Adjusted to Individual Patients . . . . . . . . . . . . . . . . . . . . . .467

XIII Contents

VII 62 63

64 65 66 67

68

Pro and Contra

In Support of a Standard Technique for Inguinal Hernia Repair . . . . . . . . . . . . . . . . . . . . .475 In Support of Individual Selection of Technique as Related to the Patient– Improvement by Better Selection of Patients Who Can Be Offered a Less Risky Technique: Groin Hernia . . . . . . . . . . . . . . . . . . .479 In Support of Standard Procedure in Abdominal Hernia Repair . . . . . . . . . . . . . . . . . .485 In Support of Individualized Procedures in Abdominal Wall Hernia Repair . . . . . . . . . . .493 In Support of Standard Procedure in Hiatal Hernia Repair . . . . . . . . . . . . . . . . . . . . . . . .503 Strategy To Improve the Results? In Support of Individualized Procedures in Hiatal Hernia Repair . . . . . . . . . . . . . . . . . . . . .513 Questionnaire . . . . . . . . . . . . . . . . . . . . . . . . . . . . .521 Subject Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .525

I

I

Risk for the Spermatic Cord

1

Are There Adverse Effects of Herniorrhaphy Techniques on Testicular Perfusion? – 3

2

The Effects of Mesh Bioprosthesis on the Spermatic Cord Structures in a Rat Model – 13

3

Damage to the Spermatic Cord by the Lichtenstein Procedure in a Pig Model–Preliminary Results – 21

4

Influence of Prosthetic Implants on Male Fertility in Rabbits and Rats – 29

5

The Effects of a Mesh Bioprosthesis on the Spermatic Cord Structures – 39

6

Influence of Prosthetic Implants on Male Fertility in Rats – 43

7

What Can We Do To Decrease the Risk of Vas Deferens Injury due to Inguinal Hernioplasty? – 49

8

The Long-Term Effect on Testicular Function of a Mesh Bioprosthesis Used for Inguinal Hernia Repair – 57

9

Reoperation Following Lichtenstein Repair: What Do Vas and Nerves Look Like? – 65

10

Damage to the Spermatic Cord from Groin Herniorrhaphy: A Review – 71

1

Are There Adverse Effects of Herniorrhaphy Techniques on Testicular Perfusion? O. N. Dilek

4

Chapter 1 · Are There Adverse Effects of Herniorrhaphy Techniques on Testicular Perfusion?

Introduction

1 The spermatic cord anatomy has been well studied because of its important role in testicular physiology and surgery. The spermatic cord is composed of the vas deferens; testicular vessels, including the testicular artery and veins; autonomous nerves; spermatic muscle; and fascia [1]. Each of these structures can have various effects on testicular perfusion. The testicular arteries arise from the abdominal aorta just below the renal artery and travel in the intermediate stratum of the retroperitoneum to reach the internal inguinal ring and become a component of the spermatic cord [1]. In an intraoperative dissection study of over 100 spermatic cords, Beck et al. identified a single internal spermatic artery in 50% of cases, with two arteries in 30% of spermatic cords and three arteries in 20% [1]. At the internal ring, the vessels are joined by the genital branch of the genitofemoral nerve, the ilioinguinal nerve, the cremasteric artery, the vas deferens, and its artery. The testicular artery branches into an internal artery and an inferior testicular artery and into a capital artery to the head of the epididymis [1]. Human testicular parenchyma receives approximately 9 ml of blood per 100 g of tissue per minute. Silber showed that an interruption of the testicular blood supply may result in testicular atrophy [2]. The spermatic veins (testicular veins) collect the blood from the testis, epididymis, and scrotum. The testicular veins form several highly anastomotic channels that surround the testicular artery as the pampiniform plexus. This arrangement allows countercurrent heat exchange, which cools the blood in the testicular artery [1]. The vascular arrangement in the pampiniform plexus–with the counterflowing artery and veins separated only by the thickness of their vascular wall in some areas– facilitates the exchange of heat and small molecules. For example, testosterone is transported from the vein to the artery via a concentrationlimited passive diffusion process. The countercurrent exchange of heat in the spermatic cord provides blood to the testis, which is a specialized structure that functions optimally at 2–4°C lower than the rectal temperatures in normal men [3, 4]. A loss of the temperature differential is associated

with testicular dysfunction [1, 3]. At the level of the inguinal canal, the vein joins to form two or three channels and then a single vein that drains into the inferior vena cava on the right and the renal vein on the left [1, 5]. The cremasteric muscle is one of the parts of the spermatic cord. When this muscle contracts, the cord is shortened, and the testicle is moved closer up toward the body, a position that provides slightly more warmth to maintain optimal testicular temperature. When cooling is required, the cremasteric muscle relaxes, and the testicle is lowered away from the warm body and is able to cool. This phenomenon is known as the cremasteric reflex [6]. The dartos muscle is a sympathetically innervated dermal muscle layer within the scrotum, distinct from the somatically innervated cremasteric muscle. Abnormalities of dartos and cremasteric muscle innervation may impact testis thermoregulation and spermatogenesis [6]. Autonomous nerves reach the testis accompanying the testicular artery and pampiniform plexus. The vast majority of testicular nerves are sympathetic axons with vasomotor function. They innervate the small vessels supplying clusters of Leydig cells and regulate testicular luteinizing hormone receptors and blood flow [7, 8]. About 10% of people develop some type of hernia during their lifetime, and more than 750,000 hernia operations are performed in the United States each year. Hernias are seven times more common in males than in females [9]. Abramson et al. reported that the overall current risk for a male to have an inguinal hernia is 18%, and the lifetime risk is 24% [10]. Anatomically, a close relation exists between the spermatic cord and inguinal hernias. Inguinal hernias can carry the risk of ischemia of the testis by intermittent mechanical compression (pressure) on the testicular vessels [11, 12]. In some reports, color Doppler ultrasonography showed that, preoperatively, the sonographic resistive index (RI) was significantly elevated in the affected (hernia) side compared with the normal side [13]. On the other hand, Muñoz Sánchez et al. concluded that uncomplicated inguinal hernias cause no significant alterations in the arterial circulation of the testicle [14].

5 Chapter 1 · Are There Adverse Effects of Herniorrhaphy Techniques on Testicular Perfusion?

The laparoscopic totally extraperitoneal preperitoneal (TEP) hernia repair technique, which is based on the concept of tension-free high ligation of the sac, has become widely popular in surgical practice [15–18]. Lichtenstein hernia repair (LHR) is one of the most comfortable effective methods of inguinal hernia repair, and it has similarities with TEP because of the prosthetic mesh used [19]. Despite the frequency of open and laparoscopic herniorrhaphy, the effects of a hernia and its subsequent repair on testicular perfusion and function are unknown. It is presently unclear what the best method is for reconstructing the deep inguinal ring in hernia surgery with mesh implantation. Testicular dysfunction (atrophy) is one of the most dreaded sequelae of inguinal hernioplasty. However, literature findings show that testicular atrophy occurs in 0–2% of patients after herniorrhaphy [9, 20]. Yavetz et al. reported that among 8,500 patients attending a fertility clinic because of infertility, 565 men (6.65%) reported an incidence of inguinal hernioplasty with or without subsequent atrophy of the testis [21]. The preoperative and postoperative use of color Doppler ultrasound (CDUS) to evaluate the spermatic cord structure and scrotal structure has been well documented in testicular pathologies and hernias [22–24]. CDUS is extremely helpful in all cases to investigate extratesticular vascularization and testicular perfusion, with parameters optimized to display low-flow velocities, including peak systolic velocity (PSV) and end diastolic velocity (EDV). Lefort and colleagues showed that color Doppler examination of the scrotum should include measurement of intratesticular RI, as an elevated RI can be suggestive of ischemia [25]. However, most of these conditions have not been well documented using CDUS after TEP or LHR. We have discussed the previously unreported use of testicular CDUS in patients who underwent TEP or LHR. Damage to the spermatic cord structures, testicular atrophy, and dysfunction levels as a consequence of mesh application are not well known in adults. The purpose of this study was to evaluate the efficacy of prosthetic meshes on testis perfusion and testis volume with Lichtenstein and TEP hernia repair techniques.

1

Materials and Methods In our prospective randomized series of 82 patients, 26 of them (age 24–71 years) fulfilled the inclusion criteria and underwent elective herniorrhaphy for groin hernia [26]. In patients with an American Society of Anesthesiologists (ASA) score of more than II, having a hydrocele and/or a varicocele could alter the testicular function independent of the hernia repair [27, 28]. For this reason, patients with the following conditions were excluded from the study: hernia types Ia, IIb, III, or IV according to the Nyhus classification [16, 29]; ASA scores of III, IV, or V; or hydrocele and/or varicocele. Other exclusion criteria were recurrence, conversion to an open procedure, or the inability to provide informed consent. Scrotal hernias or large hernias are predisposing factors for testicular atrophy (type IIb or larger), and very small hernias (type Ia) are not suitable for TEP or LHR methods. Thus, giant scrotal hernias were also excluded in our study [26]. Each patient was randomly assigned to one of two groups: TEP (n=13, mean age 46.7±1.6 years) or LHR (n=13, mean age 54.2±2.7 years). Six of the patients had bilateral hernias (n=3 for each group). CDUS of the testes was performed on all patients the day before operation and 3 months after operation. The scrotum was examined with a linear (5 MHz) transducer (ATL Ultramark 9, USA). Color Doppler settings were optimized to detect slow flow, with the highest color gain setting allowing an acceptable signal-to-noise ratio, the lowest wall filter, and the lowest velocity scale. Ultrasound of the scrotum was performed in the supine position, and the patient was asked to hold the penis suprapubically. Blood flow parameters of the spermatic artery were evaluated and noted as PSV, EDV, and calculated RI. The investigation protocol was approved by the ethics committee of our institution. Patient groups were compared with each other, and the nonoperated side was compared with the operated side. Kruskal–Wallis and Mann–Whitney U–tests were used to evaluate the differences. A two-sided p-value 75% reduction) and were examined at the margins of the mesh samples as well as within the mesh area.

Histological Analysis

⊡ Fig. 3.2. Explanted inguinal area including testis with injected x-ray solution

Tissue specimens were embedded in paraffin. Histological investigation was performed on 3-μm sections after haematoxylin and eosin staining. All sections were processed at the same time to reduce internal staining variations. Spermatogenesis as the main testicular function was estimated histologically using the Johnsen score (⊡ Table 3.1) [11]. Immunohistochemistry was done according to the manufacturer’s instructions. For detection of proliferating cells (Ki67), we used mouse monoclonal antibody MIB-1, 1:10, from Dako (Glostrup, Denmark) and rabbit antimouse antibody 1:300 from Dako (Glostrup, Denmark) as secondary antibody. TUNEL histochemistry for the detection of apop-

24

Chapter 3 · Damage to the Spermatic Cord by the Lichtenstein Procedure in a Pig Model–Preliminary Results

⊡ Table 3.1. Johnsen score [11] 10

Complete spermatogenesis with many spermatozoa

Thermography Investigating the mean inguinal temperature at the initial incision, no differences were found comparing the PVDF mesh (34.9±0.9°C) with the PP mesh (34.7±0.9°C). Furthermore, no difference was found in testis temperature (PVDF 29.0±1.1°C; PP 29.1±1.1°C; see ⊡ Figs. 3.3 and 3.4).

9

Many spermatozoa present but germinal epithelium

8

Only few spermatozoa (20%

16%

3

15%

Bernard et al. [30]

2007

Prospective

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35

21%

10%

2

5%

Bingener et al. [31]

2007

Prospective

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30

15%

6%

6

9%

231 Chapter 30 · Clinical Results After Open Mesh Repair

References 1. Höer J, Lawong G, Klinge U, Schumpelick V (2002) Factors influencing the development of incisional hernia. A retrospective study of 2,983 laparotomy patients over a period of 10 years Chirurg 73:474–480 2. Conze J, Junge K, Klinge U, Schumpelick V (2006) Evidenzbasierte laparoskopische Chirurgie–Narbenhernie. Viszeralchirurgie 41:246–252 3. Conze J, Klinge U, Schumpelick V (2005) Incisional hernia. Chirurg 76:897–909 4. Klinge U, Conze J, Krones CJ, Schumpelick V (2005) Incisional hernia: open techniques. World J Surg 29:1066–1072 5. Korenkov M, Paul A, Sauerland S, et al. (2001) Classification and surgical treatment of incisional hernia. Results of an experts’ meeting. Langenbecks Arch Surg 386:65-–73 6. Dietz UA, Hamelmann W, Winkler MS, Debus ES, Malafaia O, Czeczko NG, Thiede A, Kuhfuss I (2007) An alternative classification of incisional hernias enlisting morphology, body type and risk factors in the assessment of prognosis and tailoring of surgical technique. J Plast Reconstr Aesthet Surg 60:383–388 7. Luijendijk RW, Hop WC, van den Tol MP, de Lange DC, et al. (2000) A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med 343:392–398 8. Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J (2004) Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg 240:578–583 9. Conze J, Kingsnorth AN, Flament JB, Simmermacher R, Arlt G, Langer C, Schippers E, Hartley M, Schumpelick V (2005) Randomized clinical trial comparing lightweight composite mesh with polyester or polypropylene mesh for incisional hernia repair. Br J Surg 92:1488–1493 10. Vestweber KH, Lepique F, Haaf F, Horatz M, Rink A (1997) Mesh-plasty for recurrent abdominal wall hernias–results. Zentralbl Chir 122:885–888 11. Leber GE, Garb JL, Alexander AI, Reed WP (1998) Longterm complications associated with prosthetic repair of incisional hernias. Arch Surg 133:378–382 12. Rios A, Rodriguez JM, Munitiz V, Alcaraz P, Pérez D, Parrilla P (2001) Factors that affect recurrence after incisional herniorrhaphy with prosthetic material. Eur J Surg 167:855–859 13. Korenkov M, Sauerland S, Arndt M, Bograd L, Neugebauer EA, Troidl H (2002) Randomized clinical trial of suture repair, polypropylene mesh or autodermal hernioplasty for incisional hernia. Br J Surg 89:50–56 14. San Pio JR, Damsgaard TE, Momsen O, Villadsen I, Larsen J (2003) Repair of giant incisional hernias with polypropylene mesh: a retrospective study. Scand J Plast Reconstr Surg Hand Surg 37:102–106 15. Machairas A, Misiakos EP, Liakakos T, Karatzas G (2004) Incisional hernioplasty with extraperitoneal onlay polyester mesh. Am Surg 70:726–729 16. Langer C, Liersch T, Kley C, Flosman M, Suss M, Siemer A, Becker H (2005) Twenty-five years of experience in incisi-

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20.

21.

22.

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25. 26.

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28.

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30.

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32.

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onal hernia surgery. A comparative retrospective study of 432 incisional hernia repairs. Chirurg 74:638–645 Israelsson LA, Smedberg S, Montgomery A, Nordin P, Spangen L (2006) Incisional hernia repair in Sweden 2002. Hernia 10:258–261 Licheri S, Erdas E, Pisano G, Garau A, Ghinami E, Pomata M (2008) Chevrel technique for midline incisional hernia: still an effective procedure. Hernia 12 (2):121-–126 Kingsnorth AN, Shahid MK, Valliattu AJ, Hadden RA, Porter CS (2008) Open onlay mesh repair for major abdominal wall hernias with selective use of components separation and fibrin sealant. World J Surg 32:26–30 Schumpelick V, Conze J, Klinge U (1996) Preperitoneal mesh-plasty in incisional hernia repair. A comparative retrospective study of 272 operated incisional hernias. Chirurg 67:1028–1035 McLanahan D, King LT, Weems C, Novotney M, Gibson K (1997) Retrorectus prosthetic mesh repair of midline abdominal hernia. Am J Surg 173:445–449 Ladurner R, Trupka A, Schmidbauer S, Hallfeldt K (2001) The use of an underlay polypropylene mesh in complicated incisional hernias: successful French surgical technique. Minerva Chir 56 :1111–1117 Wright BE, Niskanen BD, Peterson DJ, Ney AL, Odland MD, VanCamp J, Zera RT, Rodriguez JL (2002) Laparoscopic ventral hernia repair: are there comparative advantages over traditional methods of repair? Am Surg 68:291–295 Paajanen H, Hermunen H (2004) Long-term pain and recurrence after repair of ventral incisional hernias by open mesh: clinical and MRI study. Langenbecks Arch Surg 389:366–370 Le H, Bender JS (2005) Retrofascial mesh repair of ventral incisional hernias. Am J Surg 189:373–375 Kurzer M, Kark A, Selouk S, Belsham P (2008) Open mesh repair of incisional hernia using sublay technique: longterm follow-up. World J Surg 32:31–36 Marchal F, Brunaud L, Sebbag H, et al. (1999) Treatment of incisional hernias by placement of an intraperitoneal prosthesis: a series of 128 patients. Hernia 3:141–147 Millikan KW, Baptista M, Amin B, Deziel DJ, Doolas A (2003) Intraperitoneal underlay ventral hernia repair utilizing bilayer expanded polytetrafluoroethylene and polypropylene mesh. Am Surg 69:287–291 Heartsill L, Richards ML, Arfai N, Lee A, Bingener-Casey J, Schwesinger WH, Sirinek KR (2005) Open Rives-Stoppa ventral hernia repair made simple and successful but not for everyone. Hernia 9:162–166 Bernard C, Polliand C, Mutelica L, Champault G (2007) Repair of giant incisional abdominal wall hernias using open intraperitoneal mesh. Hernia 11:315–320 Bingener J, Buck L, Richards M, Michalek J, Schwesinger W, Sirinek K (2007) Long-term outcomes in laparoscopic vs open ventral hernia repair. Arch Surg 142:562–567 Chevrel JP, Rath AM (1997) The use of fibrin glues in the surgical treatment of incisional hernias. Hernia 1:9–14

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Discussion Bellows: Can you comment on the use of allogenic mesh material for instance alloderm? Schumpelick: We have never used biological meshes. Why should I use such meshes? Deysine: I totally agree that we need a better classification of incision hernias.

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Acute and Chronic Pain After Laparoscopic Incisional Hernia Repair D. Berger, M. Bientzle

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Chapter 31 · Acute and Chronic Pain After Laparoscopic Incisional Hernia Repair

Introduction Laparoscopic repair of incisional hernias is gaining increasing popularity because it has some advantages compared to open techniques [1, 2]. The frequency of infectious complications, for example, is significantly reduced. Previous studies also demonstrated reduced pain after laparoscopic incisional hernia repair, a finding that has also been pointed out in a very recent review [3–7]. In contrast, Pierce et al. clearly showed that early postoperative pain is a major issue [1]. The frequency of prolonged pain was nearly 2% in the laparoscopic group compared with 0.9% in the open group. A recent study found dissatisfying pain in 9% in the long run [8]. In our preliminary study, all patients who were laparoscopically treated for an incisional hernia were followed up in the early postoperative period using a visual analogue scale. Long-term follow-up was performed using a pain score similar to those used in other studies dealing with chronic pain.

Patients and Methods

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Since 2002, all patients treated for incisional hernias have been prospectively followed up in the early postoperative period with a visual analogue scale ranging from 0 to 10. The patients are studied twice a day in reclining and upright positions until leaving the hospital. Our preliminary evaluation comprised 100 patients. Fifty patients had a mesh derived from expanded polytetrafluoroethylene (e-PTFE), and starting in May 2004, 50 patients received a mesh derived from polyvinylidene fluoride (PVDF), Dynamesh IPOM. The distribution of age, gender, and surgical parameters such as hernia size were not different between the groups. A further clinical examination was performed after 1, 3, 6, 12 months and yearly thereafter using a simplified pain score, which is shown in ⊡ Table 31.1.

Surgical Technique The surgical technique did not differ over the years. Routinely, the whole abdominal scar was covered by

⊡ Table 31.1. Classification of long-lasting postoperative pain 0 1 2 3 4

No pain at all, very satisfied Sometimes minimal pain during work, satisfied Sometimes moderate pain during work, still satisfied Often annoying pain during work, dissatisfied Strong pain at rest, very dissatisfied

the mesh, not just the obvious fascial defect. After complete adhesiolysis of the whole abdominal wall, the falciform ligament was dissected in cases with hernias or incisions reaching the upper abdomen. In patients with hernias or incisions of the lower abdomen, the fatty tissue between the plicae mediales was dissected to open the Retzius space. The meshes were fixed with six stay sutures at the corners and in the midline in the longest extension of the mesh. Furthermore, spiral tacks were used every 3–4 cm. For covering the lower abdomen, the mesh was fixed with spiral tacks at the pubic bone and the symphysis. In cases of upper abdominal hernias, the tacks were placed in the rips at the costal arch. Diclofenac and metamizole were routinely given in the postoperative period. In some cases, piritramide was added via a patient-controlled analgesia pump. Statistical analysis was done using analysis of variance tests for repeated measurements.

Results As outlined above, the two groups did not differ concerning demographic or surgical parameters. As shown in ⊡ Fig. 31.1, the patients suffered from very strong pain during the first 3 days, especially when in an upright position. The pain scores slowly decreased from a median of 7 the morning of the first postoperative day to 4 and 3 at days 3 and 4, respectively. However, there is a significant difference between the groups: Patients treated with DynaMesh IPOM showed significantly lower pain scores for 5 days than patients who received an ePTFE-derived mesh, as shown by analysis of variance testing for repeated measurements. No further correlation of pain with other parameters–such as age, gender,

235 Chapter 31 · Acute and Chronic Pain After Laparoscopic Incisional Hernia Repair

31

8

6

4

2

0 d1ml d1ms d1el d1es d2ml d2ms d2el d2es d3ml d3ms d3el d3es d4ml d4ms d4el d4es d5ml d5ms d5el d5es

body mass index, mesh size, hernia size, duration of the procedure itself, amount and intensity of adhesions, or number of previous procedures–could be established. Chronic pain was observed only during the first 3 months of the observation period. The median pain score after 4 weeks was 1.5, which indicates minimal to moderate pain during work. Six patients were dissatisfied at that time point. Only one patient was still dissatisfied after 3 months, but the problems finally resolved without further treatment. Any correlation of chronic or persisting pain with clinical parameters could not be established because of the low number of patients. For the same reason, a differentiation between the two groups did not seem to be appropriate.

Discussion It is usually believed that a main advantage of laparoscopic procedures is reduced pain in the early

⊡ Fig. 31.1. Postoperative visual analogue scale (VAS) scores. Box plots are demonstrated. The x-axis shows the time course between day 1 and day 5, given as d1m (m morning) to d5e (e evening). The different time points differentiate between the reclining (l) and upright patient positions (s). The y-axis shows the VAS level

postoperative period, which has been proven for inguinal hernia repair [9–11]. Our own clinical experience, however, showed that after laparoscopic incisional hernia repair, the patients suffered from severe pain. The early literature described a reduced need for narcotics after laparoscopic repairs compared with conventional procedures [3–6]. Even today, a review of incisional hernia repair concluded that laparoscopy is superior compared with open techniques in terms of postoperative pain [7]. However, Pierce et al. [1] described in their analysis that »unlike most other laparoscopic procedures where incisional pain is typically minimal and relatively short lived, laparoscopic incisional hernia repair is associated with substantially more pain in the postoperative period because of the methods of mesh fixation.« Our data clearly show that our patients experienced annoying pain in the early postoperative period. The use of an elastic mesh, the properties of which are comparable to the human abdominal

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Chapter 31 · Acute and Chronic Pain After Laparoscopic Incisional Hernia Repair

wall [12], is associated with significantly reduced pain scores. For inguinal hernias, it is known that the level of pain in the early postoperative period strongly correlates with chronic pain problems [13], thus supporting the recommendation that elastic meshes should be preferred. A correlation between acute and chronic pain could not be established in our series. The number of patients studied up to now is probably too small. Some major prospective studies and reviews have observed prolonged or chronic pain in up to 9% of patients [1, 2, 8]. Unfortunately, a definition of prolonged pain is not generally given that would enable comparison among different publications. The prolonged pain is usually explained by the fixation devices, mostly transfascial sutures and tacks [4]. Local anaesthesia is recommended, followed by removal of stay sutures or tacks in otherwise untreatable cases [4]. In one series with 1.6% persistent pain, the removal of tacks or stay sutures did abolish the pain in three of six patients [14]. The success rate is not given in any other series. In our series, chronic pain resolved spontaneously after conservative treatment in all cases. However, one patient was significantly restricted in his daily activities for almost 6 months. In conclusion, laparoscopic repair of incisional hernias is a painful treatment needing subsequent analgesic postoperative therapy. Dynamesh IPOM, which exhibits a physiological elasticity [12], significantly reduces the pain level in the early postoperative period. The number of patients studied does not allow any conclusion about the nature of chronic pain. An association between acute and chronic pain could not be established for laparoscopic incisional hernia repair.

References 1. Pierce RA, Spitler JA, Frisella MM, Matthews BD, Brunt LM (2007) Pooled data analysis of laparoscopic vs. open ventral hernia repair: 14 years of patient data accrual. Surg Endosc 21:378–386 2. Carlson MA, Frantzides CT, Shostrom VK, Laguna LE (2008) Minimally invasive ventral herniorrhaphy: an analysis of 6,266 published cases. Hernia 12:9–22 3. Carbajo MA, Martin DOJ, Blanco JI, de la Cuesta C, Toledano M, Martin F, Vaquero C, Inglada L (1999) Laparoscopic treatment vs open surgery in the solution of major

4.

5.

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8.

9.

10.

11.

12.

13.

14.

incisional and abdominal wall hernias with mesh. Surg Endosc 13:250–252 Heniford BT, Park A, Park AF, et al. (2003) Laparoscopic repair of ventral hernias: nine years’ experience with 850 consecutive hernias. Ann Surg 238:391–400 LeBlanc KA, Booth WV, Whitaker JM, Bellanger DE (2001) Laparoscopic incisional and ventral herniorraphy: our initial 100 patients. Hernia 5:41–45 Park A, Birch DW, Lovrics P (1998) Laparoscopic and open incisional hernia repair: a comparison study. Surgery 124:816–821 Misiakos EP, Machairas A, Patapis P, Liakakos T (2008) Laparoscopic ventral hernia repair: pros and cons compared with open hernia repair. JSLS 12:117–125 Stickel M, Rentsch M, Clevert DA, Hernandez-Richter T, Jauch KW, Lohe F, Angele MK (2007) Laparoscopic mesh repair of incisional hernia: an alternative to the conventional open repair? Hernia 11:217–222 Bringman S, Ramel S, Heikkinen TJ, Englund T, Westman B, Anderberg B (2003) Tension-free inguinal hernia repair: TEP versus mesh-plug versus Lichtenstein: a prospective randomized controlled trial. Ann Surg 237:142–147 Collaboration EH (2000) Laparoscopic compared with open methods of groin hernia repair: systematic review of randomized controlled trials. Br J Surg 87:860–867 Grant AM (2002) Laparoscopic versus open groin hernia repair: meta-analysis of randomised trials based on individual patient data. Hernia 6:2–10 Junge K, Klinge U, Prescher A, Giboni P, Niewiera M, Schumpelick V (2001) Elasticity of the anterior abdominal wall and impact for reparation of incisional hernias using mesh implants. Hernia 5:113–118 Callesen T, Bech K, Kehlet H (1999) Prospective study of chronic pain after groin hernia repair. Br J Surg 86:1528– 1531 Wassenaar EB, Raymakers JT, Rakic S (2007) Removal of transabdominal sutures for chronic pain after laparoscopic ventral and incisional hernia repair. Surg Laparosc Endosc Percutan Tech 17:514–516

Discussion Flament: When you report about the hernia size

you spoke only about the diameter. But there is still another dimension: The volume of herniated bowel. Therefore we do a CT-scan before the operation to measure the volume of the bowel in the abdominal cavity and the volume of the herniated bowel to exactly estimate the size of the hernia. Berger: Your approach is very sophisticated and would be the best of course. Schippers: You use a minimal invasive approach and you use a bridging technique and you have a

237 Chapter 31 · Acute and Chronic Pain After Laparoscopic Incisional Hernia Repair

long period of postoperative pain. What is your explanation of this pain? Berger: I can only speculate. I think that a fixation trough the peritoneum is the main problem. Chowbey: A secret of good result in laparoscopic hernia repair depends on the selection of patients. In what cases laparoscopic hernia repair can be done and what cases it cannot be done laparoscopically? Another thing is the number of used tackers for the mesh fixation. If you use too much tackers the risk of pain raises. Berger: I agree concerning your remark about the number of tackers. However, I never found a recommendation of the number of tackers used in study dealing with laparoscopic hernia repair. Of course there are some hernias that cannot be repaired laparoscopically. If we cannot reach an adequate overlap – at least five centimeters on both sites – we do an open procedure.

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Effect of Nerve Identification on the Rate of Postoperative Chronic Pain Following Inguinal Hernia Surgery S. Alfieri, D. Di Miceli, R. Menghi, G. Quero, C. Cina, G. B. Doglietto

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Chapter 32 · Effect of Nerve Identification on the Rate of Postoperative Chronic Pain Following Inguinal Hernia Surgery

Introduction The ilioinguinal nerve, iliohypogastric nerve, and inguinal segment of the genital branch of the genitofemoral nerve all cross the inguinal channel and consequently are vulnerable to injury. But if they are injured, is there any evidence that they can produce pain syndromes? Should a suspected injured nerve or a nerve in the way of repair be cut (divided), resected, or left in place? Should the cut end of the nerve be left exposed or buried in the muscle? Much controversy still exists regarding how to treat these three inguinal nerves during hernia repair, with many published studies showing contrasting results. Consequently, it is right to wonder about the following: ▬ Do the inguinal nerves really play a role in the genesis of postherniorrhaphy inguinodynia and orchialgia? ▬ Is there any scientific evidence today that chronic pain is related to the different treatment reserved for the three inguinal nerves during hernia repair?

32

In trying to give scientific answers to these questions, we have evaluated not only the levels of evidence (LE) and grades of recommendation (GR) for every published study in this field, but we also read each paper in its entirety and evaluated its statistical validity and the terminology used. It is not surprising that we discovered some discrepancies between the data found in the article and the conclusions extrapolated by systematic reviews (LE, 1a; GR, A).

Definitions and Terminology An important issue is the need to provide uniform terminology to be used in this field. In fact, the terms division, resection, dissection, transection, section, and neurectomy were often used and reported incorrectly in the literature, which influenced and distorted the real results of the studies, with important and practical implications involving the treatment of chronic pain [1]. A clear example of this is demonstrated by the wrong interpretation of the study by Picchio et al.

[2], which is often cited as demonstrating that pain is not affected by elective division of the ilioinguinal nerve. However, when reading the whole paper, it is possible to learn that the authors actually performed a neurectomy (dividing the nerve lateral to the internal ring) instead of a simple division of the nerve in the operative field. Consequently, the results of this paper not only have often been distorted but also may give the erroneous message that the nerves may be sectioned during operation at any level of the inguinal canal without any consequence [3]. With the aim of providing uniform terminology, the international consensus conference held in Rome in April 2008 decided to recommend the following nomenclature: ▬ Cutting or dividing a nerve means interrupting the continuation of a nerve. It is appropriate to mention the way the cut ends were handled, such as by ligation, cauterisation, or nothing. ▬ Resection of a nerve or neurectomy means removing the segment of a nerve along the inguinal canal. It is recommended to cut the proximal end up to its intramuscular part. It is appropriate to mention the handling of the cut ends and the proximal and distal parts of the section.

Is There Any Correlation Between Chronic Pain and Identifying vs. Not Identifying the Three Inguinal Nerves? Although it has been demonstrated that preoperative identification of all inguinal nerves is almost always possible [4], the majority of surgeons continue to not detect them, as recently emphasised and confirmed for the iliohypogastric nerve (detected in only 32% of cases) and for the genital branch of the genitofemoral nerve (detected in only 36% of cases) [5]. In fact, the vast majority of the studies report data for only one nerve (generally the ilioinguinal nerve, probably because is the easiest to recognise during hernia repair) without giving any data concerning the other two nerves, neglecting the fact that all three nerves contribute to the sensory innervation of the groin.

241 Chapter 32 · Effect of Nerve Identification on the Rate of Postoperative Chronic Pain

An Italian prospective multicentre study of 973 cases and a French single-centre study of 1,332 cases are the only two published studies presenting results for all three inguinal nerves (2,305 cases altogether) with a long follow-up period (1–5 years) [6, 7]. Both studies concluded that identification and preservation of all three inguinal nerves (which occurred in 924 patients considering the two papers together) during open inguinal hernia repairs (with or without mesh) reduces chronic incapacitating groin pain to less than 1%; the mean incidence of chronic pain was 0.8% (range 0–1.6%). The Italian study also demonstrated that the risk of developing inguinal pain increased with the number of nerves concomitantly undetected. Likewise, the division of nerves strongly correlated with the presence of chronic pain [7]. According to the data in the literature, we can conclude that identifying and protecting the three inguinal nerves decreases the risk of postoperative severe chronic pain.

Should the Identified Nerve Be Preserved, Divided, or Resected (Neurectomy)? All of the published studies report data concerning division versus preservation of only a single nerve, without giving any data concerning the other two nerves. In all of these papers, the results are distorted because the nerves not considered could have been unintentionally divided or injured during operation. For these reasons, chronic pain could be generated [8]. The studies by Ravichandran et al. [9] (LE, 2b; GR, B) and Mui et al. [10] (LE, 1b; GR, A) report results of preservation versus neurectomy of only one single nerve, and these results are also limited by very small sample sizes, with only 20 patients and 50 patients in each arm. Therefore, these studies do not have substantial statistical power compared with the study of Dittrik et al. [11] (LE, 2b; GR, B), which also did not have homogeneous distribution between the two arms (66 patients versus 24 patients). In these cases, no conclusions can be evaluated, even if some studies are prospective and ran-

32

domised and apparently have the highest recommendation grade [3]. These underpowered studies are sometimes used in meta-analyses or reviews by calculating a pooled mean percentage by means of a randomised model to reach some conclusions. However, data coming out of such a model that uses small studies are completely distorted. Picchio et al. [2] (LE, 1b; GR, A) reported that pain is not affected by elective division of the ilioinguinal nerve. However, by reading the whole paper (with 400 patients in each arm), one discovers that the author actually performed more of a neurectomy (dividing the nerve lateral to the internal ring) than a simple division of the nerve in the operative field. The results of this paper have been often distorted; in fact, some authors wrongly reported that the nerve was »divided,« and others stated that the nerve was dissected, without explaining that even if Picchio et al. did not report where the nerve was divided caudally, they divided the nerve lateral to the internal ring. Merely concluding that division/dissection of the ilioinguinal nerve does not increase or reduce the risk of chronic pain not only distorts the researchers’ results, but, more importantly, it may give the erroneous message that the nerves may be sectioned during operation at any level of the inguinal canal without any consequence. Picchio et al. [2] (LE, 1b; GR, A) report that pain is not affected by elective neurectomy (according to the new nomenclature of the consensus conference) of the ilioinguinal nerve, and Pappalardo et al. [12] report this for iliohypogastric neurectomy. According to the literature, we can conclude that identification and protection of all three nerves during open inguinal hernia repair (with or without mesh) reduces the risk of chronic incapacitating pain to less than 1%.

Should the Identified Nerve Be Isolated or Left in its Natural Bed Without Manipulation, Taking Care To Not Remove the Covering Fascia of the Nerve? No published data are available regarding manipulation versus no manipulation of a preserved nerve. However, considering the anatomical stud-

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Chapter 32 · Effect of Nerve Identification on the Rate of Postoperative Chronic Pain Following Inguinal Hernia Surgery

ies [4], we suggest (LE, 5; GR, D) leaving the the nerves in their natural bed as much as possible and not removing the covering fascia.

Should a Suspected Injured Nerve or a Nerve in the Way of Repair Be Saved by All Means or Resected?

32

The current literature is inconsistent concerning this point. Opinions differ considerably, but no published data are actually available. Some authors emphasise that when an injury has occurred, the intramuscular portion of the nerve must be resected, stating that merely dividing the nerve at the point of its emergence is inadequate [3, 5]. These data are supported by the increasing success rates of pain relief with extended versus standard neurectomy procedures, as obtained by Amid et al. [5] for patients with chronic postherniorrhaphy pain (LE, 4; GR, C) and by Alfieri et al. [6], who reported that the increased risk of developing chronic pain with the number of nerves divided could be explained by the fact that resection of the unidentified nerve has generally been performed distal to its origin; this leaves the site of the injured nerve intact–and able to continue to generate a pain signal–and exposes it to neuroma formation (LE, 5; GR, D). At the same time, there is no scientific evidence that the cut end of the nerve should be left exposed or buried in the muscle. While we await definitive results in the literature, it is reasonable to remove a suspected injured nerve or a nerve in the way of the repair during any type of repair and to implant the proximal cut end in the muscle (LE, 5; GR, D).

How Can the Inguinal Segment of the Genital Branch of the Genitofemoral Nerve Be Identified and Protected During the Open Procedure? Identifying and protecting the inguinal segment of the genital branch nerve during hernia repair is not difficult. It can be recognised, identifying and keeping the external spermatic vein (the socalled blue line) with the cord. However, the geni-

tal branch nerve can be damaged if inadvertently sectioned, entrapped, or secured (for example, if a continuous suture is introduced along the inguinal ligament), or it can be injured if the external spermatic vessels are divided to skeletonise the cord without its identification.

Should the Cremasteric Layer Be Saved or Resected? No published data are available in the literature. However, it is advisable for hernia mesh repair to save the cremasteric layer to reduce the risk of ilioinguinal and genital branch nerve damage and thus avoid possible incapacitating and chronic postoperative pain (LE, 5; GR, D).

Should the Cut Ends of the Nerve Be Left Alone, Ligated, or Cauterised? No scientific data are reported in the literature concerning the treatment of the cut ends of the nerves.

When Glue Is Used, Should We Still Identify and Protect the Nerves? No data are present in the literature concerning whether nerves should be identified and protected even if glue is used. However, it is reasonable to consider that nerves should be identified and protected in any case (LE, 5; GR, D).

Is There Convincing Evidence that Prophylactic Division or Resection of Nerves During Hernia Repair Will Reduce the Rate of Chronic Pain? Three randomised trials examined the effect of prophylactic neurectomy on chronic pain [2, 9, 10]. In all of the trials, the ilioinguinal nerve was either divided or partially resected and the patients assessed for pain, numbness, and touch and pain sensation at 1, 6, and 12 months. None of the

243 Chapter 32 · Effect of Nerve Identification on the Rate of Postoperative Chronic Pain

studies found differences in pain or numbness, although one found significant improvements in activities such as cycling and walking in favour of the nerve division group. In a prospective multicentre study of 973 patients undergoing inguinal hernia repair in which all nerves were identified [6], nerve division was associated with an increased risk of moderate to severe pain. According to the published results in the literature, we can conclude that there is no evidence that prophylactic neurectomy reduces chronic pain after inguinal hernia repair. On the contrary, indirect evidence suggests that identification and preservation of all nerves may be beneficial. However, further studies addressing this issue are required.

Conclusions The data would suggest that if one or more nerves is not detected during surgery, it is possible that they could be inadvertently sectioned, entrapped, or secured (for example, if a continuous suture is introduced along the inguinal ligament), or they could be injured (such as if the external spermatic vessels are divided to skeletonise the cord). It should not be forgotten that nerves are most often injured when the surgeon is unaware of their location and course, or when he or she fails to recognise them during surgery. Caution is stressed when teaching this common procedure to resident physicians. Finally, it is very important to develop a uniform terminology for this field in order to better analyse and compare the studies and thereby avoid giving wrong messages to the community.

4.

5.

6.

7.

8.

9.

10.

11.

12.

32

preserve the 3 inguinal nerves during hernia repair? Ann Surg 2008; 247(6) Wijsmuller, A.R., et al. Nerve-identifying inguinal hernia repair: a surgical anatomical study. World J Surg 2007; 31(2):414–420; discussion 421–422 Amid P.K., Hiatt J.R. New understanding of the causes and surgical treatment of postherniorrhaphy inguinodynia and orchialgia. J Am Coll Surg 2007; 205(2):381–385 Alfieri S., Rotondi F., Di GiorgioA., Fumagalli U., Salzano A., Di Miceli D., Ridolfini M.P., Sgagari A., Doglietto G.B., Groin Pain Trial Group. Influence of preservation versus division of ilioinguinal, iliohypogastric, and genital nerves during open mesh herniorrhaphy: prospective multicentric study of chronic pain. Ann Surg 2006; 243(4):553–558 Izard G., Gailleton R., Randrianasolo S., Houry R. Treatment of inguinal hernias by McVay’s technique in a series of 1332 cases. Ann Chir 1996; 50(9):755–756 Alfieri S., Di Miceli D., Doglietto G.B. Prophylactic ilioinguinal neurectomy in open inguinal hernia repair. Ann Surg 2007; 245(4):663 Ravichandran D., Kalambe B.G., Pain J.A. Pilot randomized controlled study of preservation or division of ilioinguinal nerve in open mesh repair of inguinal hernia. Br J Surg 2000; 87(9):1166–1167 Mui W.L., Ng C.S., Fung T.M., Cheung F.K., Wong C.M., Ma T.H., Bn M.Y., Ng E.K. Prophylactic ilioinguinal neurectomy in open ilioinguinal repair: a double-blind randomized controlled trial. Ann Surg 2006; 244(1):27–33 Dittrick G.W., Ridl K., Kuhn J.A., McCarty T.M. Routine ilioinguinal nerve excision in inguinal hernia repairs. Am J Surg 2004; 188(6):736–740 Pappalardo G., Frattaroli F.M., Mongardini M., Salvi P.F., Lombradi A., Conte A.M., Arezzo M.F. Neurectomy to prevent persistent pain after inguinal herniorrhaphy: a prospective study using objective criteria to assess pain. World J Surg 2007; 31(5):1081–1086

Discussion Amid: To present the results of the consensus con-

ference in ten minutes is not enough time. Schippers: One of your recommendations was to

References 1. Alfieri S., Di Miceli D., Doglietto G.B. Re: nerve management during open hernia repair Br J Surg 2007; 94(7):914 2. Picchio M., Palimento D., Attanasio U., Matarazzo P.F., Bambini C., Caliendo A. Randomized controlled trial of preservation or elective division of ilioinguinal nerve on open inguinal hernia repair with polypropylene mesh. Arch Surg 2004; 139(7):755–758 3. Alfieri S. Is there a consensus concerning the relationship between post-operative chronic pain and treatment to

leave the nerve where it was. You recommend not touching the nerve anyway. But with this recommendation you have problems to do the Shouldice repair properly. Alfieri: But this is just a personal comment and the evidence level is very low.

33

Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair: A Report from the SMIL Study Group A. Montgomery

246

Chapter 33 · Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair

Introduction

33

Hernia recurrence used to be the main outcome measurement when reporting on the results of inguinal hernia surgery. Today the problem of recurrence is limited as a result of standardised mesh techniques. A recurrence does not always result in a problem for the patient, and if it does, it can usually be resolved after a new repair. Chronic pain and discomfort is considered to be the most important outcome measure of inguinal hernia repair. Chronic pain and discomfort are often difficult to handle, and even small constant problems can be an annoying reminder to the patient of the former hernia. This is why the indications for surgery must be very strict. The study on »watchful waiting« in patients with very mild symptoms is therefore of great importance in this respect [1]. Chronic pain is commonly defined as pain or discomfort that lasts for more than 3 months postoperatively. The incidence of chronic pain varies widely in different publications: between 0% and 75% in open mesh repair and between 0% and 29% after laparoscopic hernia repair [2–4]. Most of the problems are described as mild discomfort. Pain affecting daily activities has been reported to be as high as 5–6% [5, 6]. Some authors claim that mesh repair results in less chronic pain than nonmesh repair and that laparoscopic repair is more favourable than open mesh repair in this regard [7–9]. The lack of description and definition of postherniorrhaphy pain and discomfort is a problem, making it impossible to compare the results from different studies. Professor Kehlet from Denmark and his colleagues have called for »uniform assessment on postherniorrhaphy pain« to facilitate interpretation of further studies [10]. Such assessment is complicated, though, and must take many aspects into account. Fränneby et al. have attempted this by constructing an 18-question form, a specific inguinal pain questionnaire called the IPQ, which has been validated [11]. Another problem is that the patients who are included in different studies often show a mixture of different techniques for both open and laparoscopic repair and for primary and recurrent hernias, and there are variations in the length of follow-up. An additional complication is the number of patient

drop-outs for the long-term follow-up. The method of follow-up is also important. A clinical examination and a standardised protocol are seldom used. Several large randomised studies comparing laparoscopic to open repair for primary unilateral inguinal hernias with a long follow-up have been performed, with a primary end point of recurrence rate. Most of these studies were initiated during the 1990s. Chronic pain is reported as a secondary end point [12–15]. The SMIL study group described below has reported on some large randomised studies. This chapter mainly concentrates on the discussion of chronic pain and discomfort from the first study–SMIL I.

SMIL Study Group The Swedish Multicentre Trial of Inguinal Hernia Repair by Laparoscopy study group (SMIL for short) was formed in 1993 to evaluate the possible benefit of laparoscopic repair compared with open techniques. The aim was to conduct well-designed large multicentre randomised controlled trials within general surgeon practices in the normal clinical setting. The group has conducted two large studies comparing laparoscopic and open repair. SMIL I started in 1993 and compares transabdominal preperitoneal (TAPP) repair with Shouldice repair for primary inguinal hernias. This study has resulted in three publications [16–18]. SMIL II was the second large study, initiated in 1996 as a result of the development of both the laparoscopic and the open inguinal hernia repair techniques. At that time, the totally extraperitoneal (TEP) technique had been introduced, avoiding the transabdominal approach. At the same time, larger meshes were recommended for a larger overlap of the hernial orifices, with the aim of reducing the risk of a recurrence. In this study, TEP was compared with the open mesh technique of Lichtenstein, which was the gold standard at that time. This study has resulted in two publications, and another two have been submitted [19, 20]. The third study is an early study of the use of small meshes in the laparoscopic group, comparing TAPP with Lichtenstein for recurrent hernias. This has resulted in one publication [21].

33

247 Chapter 33 · Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair

All three studies were designed with a primary end point of recurrence after 5 years.

TAPP vs. Shouldice–SMIL I The TAPP technique was compared to the open Shouldice operation in primary inguinal hernias in male patients between 30 and 70 years of age. A total of 25 board-certified surgeons using either tech-

Have you noticed signs of recurrence of your hernia (a bulge in the operated groin)? Yes

No

Do you have any other complaints? Yes

No

nique from seven different hospitals participated in the study. Both preoperative and perioperative variables were recorded, and short-term outcomes regarding pain were recorded on a visual analogue scale (VAS) daily during the first week. The patient’s functional status was also recorded. A clinical exam was performed at 1 and 5 years postoperatively, looking for recurrences and complaints, and a written questionnaire was answered at 1, 2, 3, and 5 years. The patient was asked to describe his experience of any discomfort after the operation according to the form depicted in ⊡ Fig. 33.1. In cases of suspected recurrence or severe complaints, the patient was examined clinically. Complaints were graded according to the definitions of discomfort described in ⊡ Fig. 33.2. Two independent and blinded observers performed the grading. A consensus discussion was held when opinions differed.

If yes, describe them here.

Results

⊡ Fig. 33.1. Form used by the patient to describe complaints after inguinal hernia surgery

Mild:

Occasional discomfort or pain that does not interfere with daily life

Moderate: Occasional discomfort or pain that interferes with daily life Severe:

Daily discomfort and pain that interferes with daily life

⊡ Fig. 33.2. Definitions of discomfort

A total of 1,068 patients were operated on within the study. Patient characteristics were similar in the two groups. A total of 867 patients (81.2%) were eligible for analysis after 5 years. Levels of discomfort and pain in the two groups at the different time points are reported in ⊡ Table 33.1. The total percentage of patients who experienced discomfort of any kind was 8.5% in the TAPP group and 11.4% in the Shouldice group, with no significant difference between the groups. Although discomfort was usually mild, it was severe in 0.2% of the laparoscopic group and 0.7% of the open repair group. Severe pain the first postoperative week was the only risk factor for late discomfort in the Shouldice group [odds ratio (OR) 2.25, P=0.022].

⊡ Table 33.1. Grade of discomfort at different time points in the SMIL I study (TAPP transabdominal preperitoneal) 1 Year

2 years

3 years

5 years

Tapp

Open

Tapp

Open

Tapp

Open

Tapp

Open

Mild

9.4

10.5

8.9

13.4

9.2

10.6

5.5

7.9

Moderate

3.1

3.4

2.2

2.8

2.3

3.8

2.8

2.8

Severe

0.2

0

0

0.2

0

0

0.2

0.7

Total

12.7

13.9

11.2

16.4

11.5

14.4

8.5

11.4

248

Chapter 33 · Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair

No other risk factor for late discomfort was found in either group.

Discomfort in SMIL I Compared with SMIL II The SMIL II study had the same protocol as SMIL I, but the operating techniques were different, as described above. A total of 1,370 patients were operated on, and 1,275 had a 5-year follow-up. Having the same protocol enables more appropriate comparison of all four techniques regarding postoperative pain. Discomfort at 1, 2, 3, and 5 years is shown in ⊡ Fig. 33.3. There was a statistically difference between Shouldice and TAPP only at the 2-year point. There was a statistically significant difference between Lichtenstein and TEP at all time points in favour of the TEP technique. The risk of having chronic pain was approximately twice as high in the Lichtenstein group as in the other groups at all time points; almost 20% in the Lichtenstein group reported discomfort at all time points.

%

*

The number of patients classified as having severe pain was low in both groups. Patients with severe or moderate pain were therefore merged, creating the moderate/severe pain group. The results are demonstrated in ⊡ Fig. 33.4. There was a statistically significant trend over time for a decrease in frequency of moderate/severe chronic pain for Lichtenstein repair but not for the other techniques. In a multivariable analysis, risk factors for chronic pain in the TEP group were impairment in the physical test after 1 week, longer recovery time than the median, and weight below the 3rd quartile. For the Lichtenstein group, the risk factor was pronounced postoperative pain.

Discussion Discomfort and chronic pain was not the primary end point in any of the large randomised studies comparing laparoscopic and open hernia inguinal hernia repair. Altogether, there are four studies on

*

*

*

20

33

*

18 16 14

TAPP Shouldice TEP Lichtenstein

12 10 8 6 4 2 0 1

2

3

5

years

⊡ Fig. 33.3. Total amount of discomfort for different techniques at different time points in the SMIL I and II studies. Significant differences between groups are indicated by an asterisk (*)

249 Chapter 33 · Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair

chronic pain besides the SMIL studies, including more than 400 patients [12–15]. There are huge differences in these studies in follow-up time, which varies between 1 and 5 years. There are also huge differences in the percentage of attendees at the last follow-up, varying between 61% and 96%. The definition of chronic pain is also difficult to compare among the studies, but all studies report less pain with the laparoscopic technique. However, this varies in the studies, too, being between 0% and 18% for the laparoscopic technique and between 1% and 20% for the open techniques. The overall percentage of chronic pain at 5 years in the SMIL I study was 8.5% for TAPP and 11.4% for Shouldice. This difference is, however, not significant. In SMIL II there was a bigger difference between chronic pain in the TEP-operated and Lichtenstein groups–9% and 19%, respectively. However, the high attendance, with clinical examination and a standardised questionnaire, at 5-year follow-up in both SMIL studies is one of the SMIL studies’ strengths. A heavy polypropylene mesh was fixated using a stapling device in both the TAPP and TEP

33

procedures. The same mesh was used for the Lichtenstein operation. In recent research, anchoring of the mesh has been discussed as one cause of chronic pain. Several randomised studies have been performed on different fixation techniques, showing advantages for the nonfixated or glued mesh in endoscopic methods [22–25]. The advantage of less pain by using a low-weight mesh with large pores has also been discussed [26, 26]. All in all, the endoscopic preperitoneal technique seems to be more favourable for patients from the aspect of preventing chronic pain and discomfort. Development of new meshes and avoidance of fixation might favour the patients even further.

References 1. Fitzgibbons RJ, Giobbie-Hurder A et al. (2006) Watchful waiting vs repair of inguinal hernia in minimally symptomatic men. A randomized clinical trial. JAMA 295:285– 292 2. Nienhuijs SW, van Oort I, Keemers-Gels ME, Strobbe LJA, Rosman C. (2005) Randomized clinical trial comparing

% 20 18 16 14 TAPP Shouldice TEP Lichtenstein

12 10

*

8

*

6 4 2 0 1

2

3

5

years

⊡ Fig. 33.4. Moderate or severe discomfort for different techniques at different time points in the SMIL I and II studies. Significant differences between groups are indicated by an asterisk (*)

250

3.

4.

5.

6.

7.

8.

9.

10.

11.

33 12.

13.

14.

15.

Chapter 33 · Discomfort 5 Years After Laparoscopic and Shouldice Inguinal Hernia Repair

the Prolene Hernia System, mesh plug repair and Lichtenstein method for open inguinal hernia repair. Br J Surg 92:33–38 Poolban AS, Bruce J, Smith WC, King PM, Krukowski ZH, Chambers WA. (2003) A review of chronic pain after inguinal herniorrhaphy. Clin J Pain 19(1):48–54 PageB, Paterson C, Young D, O´Dwyer PJ. (2002) Pain from primary inguinal hernia and the effect of repair on pain. Br J Surg 89(10):1315–1318 Kalliomäki ML, Sandblom G, Gunnarsson U, Gordh T. (2009) Persistent pain after groin hernia surgery: a qualitative analysis of pain and its consequences for quality of life. Acta Anaesthesiol Scand 53(2):236-246 Fränneby U, Sandblom G, Nordin P, Nyrén O, Gunnarsson U. (2006) Risk factors for long-term pain after hernia surgery. Ann Surg 244(2):212–219 Schmedt C-G, Sauerland S, Bittner R. (2005) Comparison of endoscopic procedures vs Lichtenstein and other open mesh techniques for inguinal hernia repair. A meta-analysis of randomized controlled trials. Surg Endosc 19:188–199 Bittner R, Sauerland S, Schmedt C-G. (2005) Comparison of endoscopic techniques vs Shouldice and other open nonmesh techniques for inguinal hernia repair. A metaanalysis of randomized controlled trials. Surg Endosc 19:605–615 McCormack K, Scott NW, Go PM, Ross S, Grant AM and the EU Hernia Trialists Collaboration. (2003) Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev (1)CD001785 Kehlet H, Bay-Nielsen M, Kingsnorth A. (2002) Chronic postherniorrhaphy pain–a call for uniform assessment. Hernia 6:178–181 Fränneby U, Gunnarsson U, Andersson U, Heuman R, Nordin P, Nyrén O, Sandblom G. (2008) Validation of an inguinal pain questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg 95(4):488–493 Grant AM, Scott NW, O´Dwyer PJ, on behalf of the MRC Laparoscopic Groin Hernia Trial Group. (2004) Fiveyear follow-up of a randomized trial to assess pain and numbness after laparoscopic or open repair of groin hernia. Br J Surg 91:1570–1574 Liem MSL, Van Der Graaf Y, Van Steensel CJ, Boelhouwer RU, Clevers GJ, Meijer WS, Stassen LP, Vente JP, Weidema WF, Schrijvers AJ, van Vroonhoven TJ. (1997) Comparison of conventional anterior surgery and laparoscopic surgery for inguinal hernia repair. N Engl J Med 336:1541– 1547 Johansson B, Hallerbäck B, Glise H, Anesten B, Smedberg S, Román J. (1999) Laparoscopic mesh versus open preperitoneal mesh versus conventional technique for inguinal hernia repair: a randomized multicenter trial (SCUR Hernia Repair Study). Ann Surg 230(2):225–231 Neumayer L, Giobbe-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D et al. (2004) Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med 350:1819– 1827

16. Berndsen F, Arvidsson D, Enander L-K, Leijonmarck CE, Wingren U, Rudberg C, Smedberg S, Wickbom G, Montgomery A. (2002) Postoperative convalescence after inguinal hernia surgery: prospective randomised multicenter study of laparoscopic versus Shouldice inguinal hernia repair in 1042 patients. Hernia 6:56–61 17. Arvidsson D, Berndsen FH, Larsson LG, Leijonmarck CE, Rimback G, Rudberg C, Smedberg S, Spangen L, Montgomery A. (2005) Randomized clinical trial comparing 5-year recurrence rate after laparoscopic versus Shouldice repair of primary inguinal hernia. Br J Surg 92:1085–1091 18. Berndsen F, Petersson U, Arvidsson D, Leijonmarck C, Rudberg C, Smedberg S, Montgomery A. (2007) Discomfort five years after laparoscopic and Shouldice inguinal hernia repair: a randomised trial with 867 patients. A report from the SMIL study group. Hernia 11(4):307–313 19. Ekelund A, Rudberg C, Smedberg S, Enander LK, Leijonmarck CE, Österberg J and Montgomery A. (2006) Shortterm results of a randomized clinical trial comparing Lichtenstein open repair with totally extraperitoneal laparoscopic inguinal hernia repair. Br J Surg 93:1060–1068 20. Eklund A, Montgomery A, Rasmussen I, Sandbue R, Bergkvist L, Rudberg C. (2009) Low recurrence rate after laparoscopic (TEP) and open (Lichtenstein) inguinal hernia repair. Ann Surg 249(1):33–38 21. Eklund A, Rudberg C, Leijonmarck CE, Rasmussen I, Spangen L, Wickbom G, Wingren U, Montgomery A. (2007) Recurrent inguinal hernia: randomized multicenter trial comparing laparoscopic and Lichtenstein repair. Surg Endosc 21:634–640 22. Taylor C, Layani L, Liew V, Ghusn M, Crampton N, White S. (2008) Laparoscopic inguinal hernia repair without mesh fixation: early results of a large randomised clinical trial. Surg Endosc 22(3):757–762 23. Olmi S, Scaini A, Erba L, Guaglio M, Groce E. (2007) Quantification of pain in laparoscopic transabdominal preperitoneal (TAPP) inguinal hernioplasty identifies marked differences between prosthesis fixation systems. Surgery 142(1): 40–46 24. Lovisetto F, Zonta S, Rota E, Mazzilli M, Bardone M, Bottero L, Faillace G, Longoni M. (2007) Use of human fibrin glue (Tissucol) versus staples for mesh fixation in laparoscopic transabdominal preperitoneal hernioplasty: a prospective, randomized study. Ann Surg 245(2):222–231 25. Lau H. (2005) Fibrin sealant versus mechanical stapling for mesh fixation during endoscopic extraperitoneal inguinal hernioplasty. A randomised prospective trial. Ann Surg 242:670–675 26. O’Dwyer PJ, Kingsnorth AN, Molloy RG, Small PK, Lammers B, Horeyseck G. (2005) Randomized clinical trial assessing impact of a lightweight or heavyweight mesh on chronic pain after inguinal hernia repair. Br J Surg 92:166–170 27. Junge K, Klinge U, Rosch R, Klosterhalfen B, Scumpelick V. (2002) Functional and morphologic properties of a modified mesh for inguinal hernia repair. World J Surg 26:1472–1480

34

Recurrence or Complication: The Lesser of Two Evils? A Review of Patient-Reported Outcomes from the VA Hernia Trial L. Neumayer

252

Chapter 34 · Recurrence or Complication: The Lesser of Two Evils?

Introduction Inguinal hernia is one of the most common disease states affecting men worldwide. The direct and indirect costs of this condition, with or without repair, are great. Recent studies have questioned the need for repair in asymptomatic patients; however, in both of these studies, pain and discomfort were the main reasons for a crossover to repair from the »watchful waiting« group [1, 2]. Pain is now recognized as a common complication after hernia repair. In this review we intend to address, using previously reported data [3–5], the issue of whether a recurrence–which is viewed by most surgeons as a negative outcome–is worse for the patient in the long term than pain or other complications. Further, we review predictors of complications that may help guide surgeons in the choice of operation for individual patients.

Methods

34

The methods of the U.S. Department of Veteran Affairs (VA) hernia trial comparing laparoscopic versus open tension free hernia repair, as well as the analyses performed for evaluation of patientreported outcomes and predictors of complications, have been previously reported [3–6]. The study was designed to detect a 3% difference in recurrence at 3 years and to evaluate other surgeoncentered and patient-centered outcomes (complications/death, pain, functional status, activity levels, caregiver burden, and cost). In addition, we measured patient and surgeon satisfaction. As part of this large study, two new instruments, the Surgical Pain Scale (SPS) and the Activities Assessment Scale (AAS), were developed and validated [7, 8]. All results reported herein have been previously reported [3–6]. This report serves as an amalgamation of prior analyses. As a post hoc analysis, we also evaluated the relationship between patient-reported outcomes (PROs) and recurrence or complications [4]. In particular, we sought to determine the impact of recurrence and other complications on overall patient outcome as measured by the Medical Out-

comes Study Short Form 36 (SF-36). This analysis was limited to patients who had both preoperative and postoperative PRO assessment. Cumulative rates of recurrence and complications were used. Complications were further divided into four categories: (1) hematoma/seroma, (2) orchitis, (3) neuralgia of the leg or groin, and (4) other. Patientreported outcomes included the SF-36, the SPS, the AAS, and patient satisfaction. All of these outcomes were measured at baseline and at 2 weeks, 3 months, 6 months, and 1 and 2 years postoperatively. (Patient satisfaction, however, was not measured at 2 years.) To evaluate the relationships between preoperative and postoperative PROs, we used Pearson’s correlation coefficients. Univariate comparisons among groups were performed using analysis of variance for continuous variables and chi-square or Fisher’s exact test for categorical variables. Regression analyses were employed to determine significant predictors of postoperative PROs. As previously reported, we further analyzed predictors of short-term and long-term complications and long-term pain by initially looking for potential predictors with appropriate univariate statistics. Our initial analyses revealed different predictors for open and laparoscopic techniques, so we modeled these separately. Only outcomes with at least 50 occurrences and with p-values >0.2 in univariate comparisons were entered into regression models to ensure relative stability in the models [5].

Results As reported previously 2,134 men were randomized to Lichtenstein or laparoscopic (totally extraperitoneal or transabdominal preperitoneal) repair of their inguinal hernias [3]. Although a few patients did not undergo repair, 1,983 completed an operative intervention, and 1,696 were available for 2-year recurrence assessment. Nearly all of these patients (1,603) also had PRO data at 2 years (1,526 had PRO data at 1 year). Demographics of the patients with PRO data at 1 and 2 years were similar to those of the whole group (⊡ Table 34.1) [3, 4].

253 Chapter 34 · Recurrence or Complication: The Lesser of Two Evils?

34

⊡ Table 34.1. Demographic and outcome data, adapted from Hawn et al. [5] and Matthews et al. [6] (PRO patientreported outcome) Total study N=1,983

PRO subgroup at 2 years N=1,603

Open N (%)

Laparoscopic N (%)

Open N (%)

Laparoscopic N (%)

Recurrence

41/834 (4.9)

87/862 (10.1)

37 (4.6)

68 (8.5)

Neuralgia

99/950 (10.4)

71/943 (7.5)

67 (8.4)

53 (6.6)

Hematoma

17/950 (1.8)

50/943 (5.3)

14 (1.8)

41 (5.1)

Orchitis

7/950 (0.7)

11/943 (1.2)

6 (0.8)

11 (1.4)

Other

80/950 (8.4)

86/943 (9.1)

69 (8.6)

81 (10.1)

Patients with recurrence, a complication, or both reported scores for the AAS, SPS, and physical component portion of the SF-36 that were significantly different on univariate analyses (p1 year

1.59 (1.16, 2.18)

0.004

Hernia into scrotum

2.02 (1.18, 3.46)

0.011

Prostatism

1.94 (1.34, 2.81)

0.0005

Type of hernia: recurrent

2.04 (1.27, 3.27)

0.003

Prostatism

1.71 (1.14, 2.57)

0.009

BMI: OR for each 1-unit BMI increase

1.07 (1.02, 1.12)

0.006

34 Long-term (0.631)

infection was infrequent at any time for both types of repair, and no patient required mesh removal. For both techniques, having a recurrent hernia repaired increased the likelihood of short-term complications, as did the presence of a hernia extending into the scrotum (⊡ Tables 34.2 and 34.3). Prostatism was a predictor for both short-term and

long-term complications in the laparoscopic group, while younger age was associated with long-term complications in the open group. Younger age was associated with a higher likelihood of long-term pain in both open and laparoscopic groups (the adjusted odds ratio for each 5-year increase in age was 0.82 in open repairs and 0.83 in laparoscopic repairs) [5].

255 Chapter 34 · Recurrence or Complication: The Lesser of Two Evils?

Discussion The VA hernia trial comparing laparoscopic and open tension-free inguinal hernia repair in men is one of the largest ever conducted. We planned to be able to examine both surgeon-centered (recurrence, complications, and death) and patient-centered (SF-36 functional status, surgical pain, activities) outcomes for the duration of the study, which included a minimum of 2 years of follow-up. Collecting such massive amounts of data has allowed analyses of many different outcomes. Our analysis of the relationship of patient-centered outcomes to recurrences and complications is one of the few based on prospectively collected data rather than recall data from patients mailed a survey years after their herniorrhaphy. From these further analyses, we have confirmed the findings of others that chronic pain is a significant and measurable adverse effect of hernia repair and that it is more common long term after open repairs and in younger patients. We have further elucidated that for most patients, chronic pain has a deleterious effect on overall functional status, whereas recurrence, although associated with pain, in and of itself does not negatively affect functional status as measured by the physical component score of the SF-36. In our cost-effectiveness analysis, we showed that laparoscopic repair was cost-effective for a unilateral hernia; it is possible that the finding of a decreased physical component score in patients with chronic pain and no recurrence is responsible for this finding [9]. In addition, we have identified some other predictors of complications, which will require further investigation as to whether they themselves are putative risk factors or surrogates for unmeasured factors. The strength of the VA hernia trial is that it was conducted in »real-life« practices, not in highly specialized hernia or laparoscopic centers, and therefore represents the current practice of most general surgeons. As part of the trial, data were collected prospectively, allowing analyses of many secondary outcomes. A limitation is that the study was performed within the Veterans Affairs healthcare system, in which the majority of pa-

34

tients needing inguinal hernia repair are not »good risk,« thus limiting to some extent the generalizability of our results.

References 1.

2.

3.

4.

5.

6.

7.

8.

9.

Fitzgibbons RJ, Giobbie-Hurder A, Gibbs JO, Dunlop DD, Reda DJ, McCarthy M, Neumayer LA, et al. (2006) Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trial. JAMA 295(3):285–292 O’Dwyer PJ, Norrie J, Alani A, et al. (2006) Observation or operation for patients with an asymptomatic inguinal hernia. A randomized clinical trial. Ann Surg 244(2): 167–173 Neumayer L, Jonasson O, Fitzgibbons R, Henderson W, Gibbs J, Carrico CJ, Itani K, Kim L, Pappas T, Reda D, Dunlop D, McCarthy, Hynes D, Giobbie-Hurder A, London MJ, Hatton-Ward S. (2003) Tension-free inguinal hernia repair: the design of a trial to compare open and laparoscopic surgical techniques. J Am Coll Surg 196(5):743–752 Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R, Dunlop D, Gibbs J, Reda D, Henderson W. (2004) Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med 350(18):1819–1827 Hawn MT, Itani K, Giobbie-Hurder A, McCarthy M, Jonasson O, Neumayer LA. (2006) Patient reported outcomes following inguinal herniorrhaphy. Surgery 140:198–205 Matthews RM, Anthony T, Kim LT, Wang J, Fitzgibbons JR, Giobbie-Hurder A, Reda DJ, Itani KMF, Neumayer LA. (2007) Factors associated with postoperative complications and hernia recurrence for patients undergoing inguinal hernia repair: a report from the VA Cooperative Hernia Study Group Am J Surg 194(5):611–617 McCarthy M, Chang CH, Pickard AS, Giobbie-Hurder A, Price DD, Jonasson O, Gibbs J, Fitzgibbons R, Neumayer L. (2005) Visual analog scales for assessing surgical pain. J Am Coll Surg 201(2):245–252 McCarthy M, Jonasson O, Chang CH, Pickard AS, GiobbieHurder A., Gibbs J, Edelman P, Fitzgibbons R, Neumayer L. (2005) Assessment of patient functional status after surgery. J Am Coll Surg 201(2):171–178 Hynes D, Sroupe K, Luo P, Giobbie-Hurder A, Reda D, Kraft M, Itani K, Fitzgibbons R, Jonasson O, Neumayer L, for the Veterans Affairs Cooperative Studies Program 456 Investigators. (2006) Cost-effectiveness of laparoscopic versus open mesh hernia operation: results from a Department of Veterans Affairs randomized clinical trial. J Am Coll Surg 203(4):447–457

35

Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis Outweighs That of Technique G. G. Champault

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Chapter 35 · Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis Outweighs That of Technique

Introduction

35

The true incidence of chronic pain after inguinal herniorrhaphy is unknown, and until recently it was a secondary consideration, with the recurrence rate being deemed of greater importance. The incidence was reduced by the use of prostheses [1]. As recurrences have declined, though, more attention is now being focused on other measures of success, particularly quality of life. Numerous recent studies have examined the incidence of chronic pain after operations. Grant et al. [2] reported that 9.7% of their patients experienced chronic pain after surgery, and other studies [3–6] have put the figure as high as 34%. Typically, such complaints decrease over the course of the first year [7], but a significant number of patients do develop chronic and debilitating pain [8]. With the recognition that this is more common than was previously realized, numerous authors have begun to investigate the impact of pain on quality of life [9, 10]. Various factors have been examined to determine the etiology of postoperative pain. Patient age has been implicated, with the available data indicating that younger patients have a higher likelihood of postoperative pain [5, 10]. But a recent study [7] refuted this notion, finding that the incidence of chronic pain is evenly distributed among age groups. Preoperative pain seems to be a risk factor, with multiple studies [5, 6] showing that those who report pain beforehand are more likely to develop chronic pain afterward. Certain individuals can be physiologically or psychologically predisposed to develop chronic pain. Courtney et al. [8] found that patients with such symptoms after herniorrhaphy are more likely than most other people to suffer from other chronic pain conditions. Body habitus may play a role here because obese patients can have a higher incidence of postoperative inguinodynia [10]. Ferzli et al. [11] found that the probability of developing chronic pain was more than twofold higher in those undergoing ambulatory herniorrhaphy. The type of anesthetic administered has been examined as a possible factor in this problem. Nordin et al. [12] showed that local anesthesia was associated with less chronic pain than regional or general anesthesia.

Other risk factors for chronic pain include being employed and having private health insurance [5]. Direct injury to nerves, resulting in either partial or complete transection, can lead to neuroma formation and subsequent development of chronic pain. The ilioinguinal and iliohypogastric segments of the genital branch of the genitofemoral nerves are vulnerable to injury; when injured, they can produce pain syndromes that are refractory to narcotic and multidisciplinary management techniques. Some authors have also implicated the role of mesh [13, 14]. Demirer et al. [15] showed that when peripheral nerve tissue comes in contact with polypropylene mesh, myelin degeneration associated with edema and fibrosis occurs. However, multiple studies have examined this issue, and the weight of the evidence seems to indicate that mesh does not significantly increase the risk of chronic pain [8, 10, 16]. Operative technique may also play a role. No particular surgical approach has proved superior in terms of subsequent pain, although data suggest that the laparoscopic procedure [17] may be more beneficial. Douek et al. [18] found that after 5 years, the transabdominal preperitoneal procedure resulted in significantly less pain than an open tension-free mesh repair (2% vs. 10%). In contrast, the largest study [19] to date comparing open techniques with laparoscopy found no differences after 3 months. Multiple studies have examined the role of mesh. The etiological factors include irritation or damage of inguinal nerves by sutures or mesh [13], an inflammatory reaction against the mesh [20], or simply scar tissue. A recent systematic review of mesh techniques compared with nonmesh methods pointed out that no strong evidence indicated that the use of mesh increased the rate of chronic pain [1]. Recent studies [3] have pointed out that »mesh-induced pain« occurs more frequently than reported, including in tension-free techniques. Amid [21] identified »meshoma« as a radiologic entity and pathologic cause of chronic pain. Meshoma occurs when the mesh prosthesis becomes wadded into a ball because of nonfixation, insufficient fixation, or insufficient dissection to make adequate room for the prosthesis. In other situations, the weight of the evidence seems to indicate

259 Chapter 35 · Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis

that mesh does not significantly increase the risk of chronic pain [10, 16, 18]. But research into alternatives to polypropylene continues. Cobb et al. [22] have advocated the use of newer lightweight polypropylene, which may in theory result in less foreign body response and would improve operative outcomes. Post et al. [23] reported that after 6 months of follow-up, lightweight polypropylene mesh is preferable to conventional mesh for Lichtenstein repair of inguinal hernia. After this study, two randomized studies [24, 25] reported that use of a partially absorbable lightweight mesh was associated with less chronic pain than a nonabsorbable heavy mesh after 1 and 3 years. The frequency of recurrence was similar for the two meshes. A recent laparoscopic study indicated that fewer postoperative complications and an improved quality of life can be achieved by reducing the amount of polypropylene in meshes used for laparoscopic hernia repair [26]. Foreign body sensations were also fewer for lightweight meshes compared with conventional polypropylene mesh. In this study, Horstmann et al. [26] followed their patients only 1 year after surgery, when a foreign body sensation is more common than after 2 years. On the other hand, Paajanen [14] recently compared three different meshes [partially absorbable polypropylene–polyglactin mesh, lightweight polypropylene mesh (55 g/m2), and conventional densely woven polypropylene mesh] in a randomized trial of 228 patients (232 hernias) treated by Lichtenstein tension-free hernioplasty under local anesthesia in same-day surgery by the same surgeon using exactly the same surgical technique. He found no differences in pain or quality of life after 2 years of follow-up. The nature and quality of prostheses have evolved over the last 10 years, with polypropylene being the most common material. Many prostheses have offered additional refinements: anatomical molding; inclusion of elements to reduce the residual mass of nonresorbable material, thereby diminishing complications; and, recently, coatings of substances that assist in tissue acceptance and integration. We performed a study [27] to prospectively assess the results at 2-year follow-up in patients who underwent tension-free hernia repair by either the

35

Lichtenstein technique or laparoscopy, using two types of prostheses: polypropylene and beta-D-glucan-coated polypropylene (Glucamesh, Genzyme France). Glucan-coated prostheses are composed of an unwoven polypropylene mesh that is coated with beta–(1→3),(1→4)-D-glucan, a complex carbohydrate extract of oat. Oat beta-glucan is an entirely (100%) natural plant product that has been used in burn and wound care applications [28–30]. Beta-glucans have also been the subject of research regarding their roles as immunomodulators [31–34] and agents in wound healing [35, 36].

Patients and Methods Patients Between 2001 and 2003, 410 consecutive patients (396 men, 14 women) of mean age 54 years (range 18–84) underwent repair of inguinal hernias, 96 (23%) of which were bilateral and 56 (13%) recurrent. Most patients (95%) were classified as American Society of Anesthesiologists (ASA) physical status I or II [8], and 72 (17.5%) of them had a body mass index (BMI) above 30.

Methods All surgery was done under general anesthesia by four surgeons. Thrombosis prophylaxis and antibiotic prophylaxis were used in all cases. Lichtenstein repair was performed as first described [9]. The prosthesis was fixed at the inguinal ligament with five to seven stitches of polypropylene. In laparoscopic repair (totally extraperitoneal approach, or TEP), the Retzius space was developed and insufflated using three trocars. Prostheses were not fixed. This technique was preferred for bilateral hernias or for hernias that recurred after herniorrhaphy in young (20–45 years) active professionals or sportsmen or women with no anesthetic risk and a BMI under 30. All other patients underwent Lichtenstein repair. Two types of prosthesis were used: polypropylene of weight per unit area 105 g/m2 (Bard, Ethicon) and polypropylene of weight per unit area

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Chapter 35 · Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis Outweighs That of Technique

50 g/m2 coated with beta-D-glucan (Glucamesh; Genzyme France), a plant derivative (oat) that promotes healing and has an immunomodulatory effect. Patients were randomly assigned to the two groups depending on whether they agreed to be included in a prospective study [10]. All patients were followed up prospectively for at least 2 years by a surgeon not involved in the study. Recurrence was confirmed by physical examination or repeat surgery. Chronic pain was assessed using a visual analog scale (VAS) and a validated questionnaire [11]. Pain was considered mild for a VAS score below 3, moderate below 5, and severe or debilitating above 5.

Statistics Quantitative values are given as means ± standard deviation. The Kruskal–Wallis test or Wilcoxon test was used for (nonparametric) comparison of the two groups. For qualitative parameters, percentages were compared using the chi-square test. Differences were considered statistically significant for p-values 5) as a function of mesh Glucamesh

Polypropylene

p

Totally extraperitoneal approach

1/51 (1.9%)

3/66 (4.5%)

p=0.27

Lichtenstein

0/53 (0%)

7/179 (3.3%)

p=0.02

Total

1/104 (0.9%)

10/245 (4%)

p=0.02

Glucamesh

Polypropylene

p

Groin

67%

77%

ns

Testicle

50%

34%

ns

⊡ Table 35.6. Location of pain (ns not significant)

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Chapter 35 · Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis Outweighs That of Technique

We used laparoscopy in young, nonobese patients with bilateral or recurrent hernia who were active professionally or in sports and who had no anesthetic risk. We applied the same indications to the laparoscopic and Lichtenstein groups, which were therefore perfectly comparable. The reported 2-year recurrence rate is comparable for Lichtenstein repair and laparoscopic repair (2–5%) [38, 39], which accords with our experience (2.8%) in which this incidence was independent of the technique or the prosthetic mesh. The choice of prosthesis is even less well defined and subject to criteria that are often costrelated and subjective or personal. The characteristics of the ideal prosthesis are well defined: large mesh, solid, flexible, low specific weight, ability to become incorporated in tissues, and biologically inert. Most meshes are made of polypropylene or polyester. Using these principles, a great variety of products have been developed and adapted to techniques or practices (laparoscopy): composite, two-faced meshes that are coated to promote healing and facilitate tissue integration. Coating with animal collagen has proved effective but carries a small biological risk (cattle) or is subject to religious restrictions (pig). Beta-Dglucan is an entirely natural plant product that promotes healing and has an immunomodulatory effect [29, 31, 33, 34]. Beta-D-glucan-coated meshes are effective in terms of recurrence, quality of life, and chronic pain [40, 41]. In the present study, we have shown that the 2-year recurrence rate was the same regardless of technique, mesh, or the mesh’s weight per unit area. Studies of lightweight meshes have yielded contrasting results [24, 42]. When they compared outcomes after laparoscopic TEP inguinal repair using new lightweight (28 g/m2) and traditional (85 g/m2) heavyweight mesh, Khan et al. [43] found less discomfort and pain in the lightweight group at 3-month follow-up. Severity of numbness was less with lightweight mesh, suggesting less nerve interference and less inflammatory response. Also, the use of lightweight mesh for Lichtenstein hernia repair did not affect the recurrence rate, but some aspects of pain and discomfort were improved 3 years after surgery [24].

Chronic pain after hernia repair has been studied extensively [3, 6, 17, 43] but is difficult to assess. Specific validated questionnaires [42, 44] have been developed to evaluate and compare quality of life as a function of technique. Numerous factors have been implicated: anatomical factors (nerves), type of hernia, technique, surgical field, and also the mesh and its fixation. In our practice, the meshes used in TEP are not fixed, and those used in Lichtenstein repair are fixed with a few sutures on the inguinal ligament. At 2-year follow-up, these techniques were identical in comparable groups of patients, whatever the type of prosthesis used. There was no difference in chronic pain, or even in pain qualified as severe, between TEP and Lichtenstein repair. There was, however, a significant difference in favor of Glucamesh compared with polypropylene mesh in the groups compared, irrespective of the repair technique. These advantages may stem from the low weight per unit area of Glucamesh but above all from the quality of the beta-D-glucan coating.

Conclusion Our findings suggest that at 2-year follow-up, the quality of hernia repair in terms of efficacy and quality of life is determined more by the characteristics of the prosthesis than by the technique used.

References 1. EU Hernia Trialist Collaboration (2000). Mesh compared with non mesh methods on open groin hernia repair. Systematic review of randomized controlled trial. Br J Surg 87, 854–859 2. Grant AM, Scott NW, O’Dwyer PJ (2004). Five-year follow-up of a randomized trial to assess pain and numbness after laparoscopic or open groin hernia. Br J Surg 91, 1570– 1574 3. Bay Nielsen M, Perkins FM, Kehlet H (2001). Danish Hernia Database. Pain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study. Ann Surg 233, 1–7 4. Nienhuijs SW, Boelens OB, Strobbe LJ (2005). Pain after anterior mesh hernia repair. J Am Coll Surg 200, 885–889 5. Franneby U, Sandbloom G, Nordin P, Gunnarson U (2006). Risk factors for long term pain after hernia surgery. Ann Surg 244, 212–219

263 Chapter 35 · Chronic Pain After Inguinal Hernia Repair: The Choice of Prosthesis

6. Callesen T, Beck K, Kehlet H (1999). Prospective study of chronic pain after groin hernia. Br J Surg 86, 1528–1531 7. Aasvang EK, Bay Nielsen M, Kehlet H (2006). Pain and functional impairment 6 years after inguinal herniorrhaphy. Hernia 10, 316–321 8. Courtney CA, Duffy K, Serpell MG (2002). Outcome of patients with severe chronic pain following repair of groin hernia. Br J Surg 89, 1310–1314 9. Silen W (2002). Chronic pain and quality of life following open inguinal hernia repair. Br J Surg 89, 123 10. Poobalan AS, Bruce J, King PM, Chambers WA, Krukowski ZH, Smith WCS (2001). Chronic pain and quality of life following open inguinal hernia. Br J Surg 88, 1122–1126 11. Ferzli G, Edwards E, Khoury G (2007). Chronic pain after inguinal herniorrhaphy. J Am Col Surg 205, 1, 333–341 12. Nordin P, Zetterstrom H, Guynnarson U, Nilsson E (2004). Choice of anesthesia and risk of reoperation for recurrence in groin hernia repair. Ann Surg 204, 187–192 13. Heise CP, Starling JR (1998). Mesh inguinodynia: a new clinical syndrome after inguinal herniorrhaphy. J Am Coll Surg 187, 514–518 14. Paajanen H (2007). A single surgeon randomized trial comparing three composite meshes on chronic pain after Lichtenstein hernia repair in local anesthesia. Hernia 11, 335–339 15. Demirer S, Kepenecki, Evirgen O (2006). The effect of polypropylene mesh on ilioinguinal nerve in open mesh repair of groin hernia. J Surg Res 131, 175–181 16. Koninger J, Redecke J, Butters M (2004). Chronic pain after hernia repair: a randomized trial comparing Shouldice, Lichtenstein and TAPP. Langenbecks Arch Surg 389, 361–365 17. Kumar S, Wilson RG, Nixon SJ, MacIntire IMC (2002). Chronic pain after laparoscopic and open mesh repair of groin hernia. Br J Surg 89, 1476–1479 18. Douek M, Smith G, Oshavo A (2003). Prospective randomized controlled trial of laparoscopic versus open hernia mesh repair: five years follow up. Br J Med 326, 1012– 1013 19. Neumayer L, Giobbie-Hinder A, Jonasson O (2004). Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med 350, 1819–1827 20. Di Vita G, Milano S, Frazzetta M (2000). Tension free hernia repair is associated with an increase of inflammatory response markers against the mesh. Am J Surg 180, 203– 207 21. Amid PK (2004). Radiological images of meshoma: a new phenomenon after prosthetic repair of the abdominal wall hernia. Arch Surg 139, 1297–1298 22. Cobb WS, Kercher KW, Heniford BT (2005). The argument for lightweight polypropylene mesh in hernia repair. Surg Innov 12, 63–69 23. Post S, Weiss B, Willer M, Neufang T, Lorenz D (2004). Randomized clinical trial of lightweight composite mesh for Lichtenstein inguinal hernia repair. Br J Surg 91, 44–48 24. Bringman S, Wollert S, Osterberg J, Smedberg S, Granlund H, Heikkinen T (2006). Three years results of a randomized

25.

26.

27.

28.

29.

30.

31.

32.

33.

34.

35. 36.

37.

38.

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clinical trial of lightweight or standard polypropylene mesh in Lichtenstein repair of primary inguinal hernia. Br J Surg 96, 1056–1059 O’Dwyer PJ, Kingsnorth AN, Molloy RG, Small PK, Lammers B, Horeyseck G (2005). Randomized clinical trial assessing impact of a lightweight or heavy weight mesh on chronic pain after inguinal hernia repair. Br J Surg 92, 166–170 Horstmann R, Hellwig M, Classen C, Rottgermann S, Palines D (2006). Impact of polypropylene amount on functional outcome and quality of life after inguinal hernia repair by the TAPP procedure using pure, mixed and titanium-coated meshes. World J Surg 30, 1742–1749 Champault G, Bernard C, Rizk N, Polliand C (2007). Inguinal hernia repair: the choice of prosthesis outweighs that of the technique. Hernia 11, 125–128 Delatte SJ, Evans J, Hebra A, Adamson W, Othersen HB and Tagge EP (2001). Effectiveness of beta-glucan collagen (BGC) for treatment of partial thickness burns in children. J Ped Surg 36, 113–118 Lozano DD, Noordenbos J, Hansbrough JF (2002) The use of glucan II in the treatment of donor sites. J Burn Care Rehab 23, S81 Richards T, Azad S, Dziewulski P, Moiemen N, Dziewulski P (2000). Randomized controlled trial of dressings for partial thickness facial burns. J Burn Care Rehab 21, part 2, S219 Abel G, Czop JK (1992). Stimulation of human monocyte beta-glucan receptors by glucan particles induces production of TNF alpha and IL 1Beta. Int J Immunopharmacol 14, 1363–1373 Browder W, David W, Lucore P, Petrus H, Jones E, McNamer R (1988). Effect of enhanced macrophage function on early wound healing. Surgery 104, 224–230 de Fellippe jr J, da Rocha e Silva Jr M, Maciel FM, Soares A, Mendes NF (1993). Infection prevention in patients with severe multiple trauma with the immunomodulator beta 1-3 polyglucose (glucan). Surg Gynecol Obstet 177, 383–388 Estrada A, Yun CH, Van Kessel A, Li B, Hunta S (1997). Immunomodulatory activities of oat beta-Glucan in vitro and in vivo. Microbiol Immunol 41, 991–998 Di Pietro LA (1995). Wound healing: the role of the macrophage and others immune cells. Shock 4, 233–240 Wolk M, Danon D (1985). Promotion of wound healing by yeast glucan evaluated on single animals. Med Biol 63, 273–280 Wrigland WW, Van Den Tol MP, Luijendijih RW, Hop WCP, Busschbacht JJV, de Lange DCD, Van Geldere D, Rottier AB, Vegt PA, Ijzermans JNM and Jeekel J (2002). Randomized trial of non mesh versus mesh repair of primary inguinal hernia. Br J Surg 89, 293–297 Arvidson D, Berndsen FM, Larsson LG. Leijonmarck CE, Rimback G, Rudberg C, Smedberg S, Spangen L, Montgomery A (2005). Randomized clinical trial comparing 5 years recurrence rate after laparoscopic versus Shouldice repair of primary inguinal hernia. Br J Surg 92, 1085–1091

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39. Wara P, Bay Nielsen M, Jul P, Bendix J, Kehlet H (2005). Prospective nationwide analysis of laparoscopic versus Lichtenstein repair of inguinal hernia. Br J Surg 92, 1277– 1281 40. Barrat C, Seriser F, Arnoud R, Trouette P, Champault G (2004). Inguinal hernia repair with beta glucan coated mesh: prospective multicenter study (115 cases). Preliminary results. Hernia 8, 33–38 41. Champault G, Barrat C (2005) Inguinal hernia repair with beta glucan coated mesh: results at two years follow up. Hernia 9, 125–130 42. Conze J, Kingsnorth AN, Flament JB, Simmermacker P, Arlt G, Langer C, Shippers E, Hartley A, Schlumpelick V (2005). Randomized clinical trial comparing lightweight composite mesh with polyester or polypropylene mesh for incisional hernia repair. Br J Surg 92, 1488–1493 43. Khan LR, Kumar S, Nixon SJ (2006). Early results for new lightweight mesh in laparoscopic totally extraperitoneal inguinal hernia repair. Hernia 10, 303–308

Discussion Schumpelick: Thank you very much for this pre-

35

sentation, I think these are excellent results. How do you explain your results? How is glucan working? Champault: I think there are three explanations: First, it’s a lightweight mesh. Second, there is no fixation, because of adhesiveness. Especially in TEP hernia repair we do not fix the mesh anymore. Schumpelick: Is glucan like a glue? Champault: There is no glue on this mesh. But when you use this mesh in TEP hernia repair and you put the mesh directly on the muscle, you don’t need any fixation or tacks. And when you perform a Lichtenstein hernia repair, you only have to put in the prosthesis. In this study we used the official technique described by Amid with a running suture on the inguinal ligament. And third, with regard to the role of glucan, I have seen the use of glucan in burned patients. There it is very efficient, and you win many days in healing. Perhaps there is an action in the integration of the prosthesis in the muscle and possibly, as the experimental studies have shown, an action of the inflammatory reactions. Schumpelick: And then you mentioned in your discussion the covering of meshes with collagen. Is that not working anymore? Champault: There is a problem with collagen because you use the same product of collagen to fa-

cilitate the integration in the muscle and secondly to avoid an adherence. And that is a paradox. In the literature there is no A-level publication showing the usefulness of collagens. And the company (Covidien) have put the same prosthesis without collagen on the market – to be in the prize only! Post: You cannot differentiate the difference between the effect of lightweight and heavyweight and the glucan. So it might be hypothesized that the only difference is due to the light weight and not to glucan. In your randomized trial you started just now, do you compare the same lightweight with and without glucan? Champault: It probably will be the next trial. Smeds: Very interesting results. In order to understand the mechanisms more, I am just curious to know whether you allocated the surgeons to the different type of meshes. Did you have the polypropylene surgeons and the glucan surgeons? Because we know that there is a significant difference if you are a high-volume surgeon or a low-volume surgeon. Champault: No, the same surgeons. In a previous study we have shown that the results of trainees are the same as the results of consultants or more experienced surgeons. In this study, the repairs were performed within the whole group of our surgeons.

36

The Effect of Polypropylene Mesh on the Ilioinguinal Nerve in Open Mesh Repair of Groin Hernia S. D. Demirer, I. Kepenekci, O. Evirgen, O. Birsen, A. Tuzuner, S. Karahuseyinoglu, M. Ozban, E. Kuterdem

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Chapter 36 · The Effect of Polypropylene Mesh on the Ilioinguinal Nerve in Open Mesh Repair of Groin Hernia

Introduction

Material and Methods

Open or laparoscopic mesh repair of groin hernia is one of the most common elective operations performed by general surgeons. Because of low recurrence rates, the concept of tension-free mesh repair methods has gained wide acceptance. The development of chronic pain after inguinal hernia repair is a well-known long-term complication, with the reported frequency of pain varying from 0% to 37% [1–11]. Some studies have reported a lower incidence of pain, 2–2.5%, after laparoscopic hernia repair than after open mesh repair [3, 4, 8, 11–15]. The complaint of chronic pain following inguinal hernia repair can continue for months or even years. Several risk factors associated with this have been identified, including recurrent hernia repair, the patient’s insurance status, day surgery, patient age less than 60 years, intensity of early postoperative pain, experience of the surgeon, and type of surgical procedure used [3, 6, 9, 16]. Mesh inguinodynia was described as »a new clinical syndrome« after inguinal herniorrhaphy. The development of this chronic debilitating pain after herniorrhaphy has been attributed to several mechanisms, including injury or entrapment of the sensory nerves (ilioinguinal, iliohypogastric, genitofemoral, or lateral femoral cutaneous nerves) and mesh inguinodynia [2, 3, 6–8, 17]. Partial or complete division, neuroma formation, stretching, contusion, crushing, electrical damage, or suture compression can injure sensory nerves in close proximity to the operative field and cause neuralgia. Secondary damage to a sensory nerve may also result from scar tissue compression or from irritation by an adjacent inflammatory process such as a suture granuloma or mesh. Polypropylene synthetic mesh causes inflammatory reaction and formation of scar tissue [2, 6, 8, 11, 17, 18]. The ilioinguinal nerve is a sensory nerve that is usually preserved during hernia repair, but it can interfere with placement of the mesh and may be traumatized inadvertently during operation. In this experimental study, we aimed to evaluate damage or entrapment of the ilioinguinal nerve caused by polypropylene synthetic mesh after groin hernia repair.

Our study protocol was reviewed and approved by the ethics committee of Ankara University School of Medicine. All animals received humane care in accordance with the Guide for the Care and Use of Laboratory Animals prepared by the National Academy of Sciences and published by the U.S. National Institutes of Health (NIH publication No. 85–23, revised 1985).

Experimental Design Twenty-four New Zealand rabbits weighing 2.4– 2.7 kg were included in our study. They were subjected to 1 week of preliminary conditioning during which time they received standard chow and water ad lib. They were housed in a temperatureand humidity-controlled environment, two per cage, with a 12-h light–dark cycle. Preoperative antibiotics (cefazolin 10 mg/kg) were administered intramuscularly 30 min prior to skin incision. The rabbits were anesthetized by an intramuscular injection of ketamine hydrochloride (35 mg/kg) and Xylocaine (5 mg/kg). The animals were placed in a dorsal recumbent position, followed by hair removal from the inguinal area. The inguinal and scrotal regions were shaved and prepared with Betadine solution. In all animals, the inguinal areas were explored bilaterally through an inguinal incision. The ilioinguinal nerve was identified on both sides and synthetic polypropylene mesh placed on only one side (⊡ Fig. 36.1). The ilioinguinal nerve was in touch with polypropylene mesh on this side (⊡ Fig. 36.2). We designated the right groin as the control and the left groin as the experimental side in each animal. After the operation, the inguinal incisions were closed in anatomical layers with 3-0 monofilament suture. All rabbits tolerated the surgery well, and they were followed until reexploration. Three months after surgery, the animals were anesthetized using intramuscular ketamine hydrochloride, and bilateral inguinal exploration was performed again, with samples of nerve tissue taken from both sides. The samples of nerve tissue were divided into two groups as control and experimental groups. An internation-

267 Chapter 36 · The Effect of Polypropylene Mesh on the Ilioinguinal Nerve

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and examined under a light microscope (Zeiss Axio Scope photomicroscope). After double staining with uranyl acetate and lead citrate, ultrathin sections were examined and photographed using a LEO 906E transmission electron microscope. For light microscopic study, inguinal peripheral nerve tissues were fixed in 10% formaldehyde. Samples were dehydrated by immersion in a series of alcohol concentrations and embedded in paraffin; 5-μm sections were stained with hematoxylin and eosin (H&E) and Masson’s trichrome and examined under a light microscope. ⊡ Fig. 36.1. Ilioinguinal nerve of the rabbit after dissection

Morphometric Analysis

⊡ Fig. 36.2. Polypropylene mesh was laid in close proximity to the ilioinguinal nerve

For morphometric analysis, photographic color images from semithin sections of experimental and control groups were obtained with the Zeiss Axio Scope photomicroscope at ×250 magnification. The measurements were obtained using Adobe Photoshop 7.0 software. The graphic file format of the images is JPEG, and resolution was set at 500 pixels per inch. Myelinated fiber diameter, axon diameter, G-ratio (axon diameter/myelinated fiber diameter), myelin thickness, and the numbers of nerve fibers with diameters of ≤4 μm, 5–8 μm, and ≥9 μm were assessed in a blinded fashion using a semiautomated procedure [20].

Statistics ally accepted standard definition of pain persisting beyond the normal tissue healing time, assumed to be 3 months, was used in our study [19].

Histological Tissue Processing For electron microscopic study, inguinal peripheral nerve specimens from the control and experimental groups were fixed in 2.5% glutaraldehyde in 0.1 M phosphate buffer and postfixed in 1% osmium tetroxide. Tissue samples were dehydrated through a graded series of ethanol and propylene oxide embedded in araldite. Semithin sections were stained with toluidine blue-Azure II

Statistical analysis was performed using the adjusted Student‘s t-test for clustered data and the adjusted chi-square test for clustered binary data, comparing the mesh-laid side of each group to the control side of the same group. A p-value