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CEITH NIKKOLO Impact of Different Mesh Parameters on Chronic Pain and Foreign Body Feeling After Open Inguinal Hernia Repair

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CEITH NIKKOLO Impact of Different Mesh Parameters on Chronic Pain and Foreign Body Feeling After Open Inguinal Hernia Repair DISSERTATIONES CEITH NIKKOLO MEDICINAE UNIVERSITATIS TARTUENSIS 229 Impact of different mesh parameters on chronic pain and foreign body feeling after open inguinal hernia repair body feeling pain and foreign mesh parameters on chronic Impact of different CEITH NIKKOLO Impact of different mesh parameters on chronic pain and foreign body feeling after open inguinal hernia repair Tartu 2014 ISSN 1024-395X ISBN 978-9949-32-694-5 DISSERTATIONES MEDICINAE UNIVERSITATIS TARTUENSIS 229 DISSERTATIONES MEDICINAE UNIVERSITATIS TARTUENSIS 229 CEITH NIKKOLO Impact of different mesh parameters on chronic pain and foreign body feeling after open inguinal hernia repair Department of Surgery, University of Tartu, Estonia The dissertation has been accepted for the commencement of the degree of Doctor of Philosophy in Medicine on 28th August 2014 by the Council of the Faculty of Medicine, University of Tartu, Estonia Supervisors: Urmas Lepner, MD, PhD, Associate Professor, Department of Surgery, Faculty of Medicine, University of Tartu, Estonia Reviewers: Peep Talving, MD, PhD, FACS, Visiting Professor, Department of Surgery, Faculty of Medicine, University of Tartu, Estonia Aare Märtson, MD, PhD, Associate Professor, Department of Traumatology and Orthopaedics, Faculty of Medicine, University of Tartu, Estonia Opponent: Hannu Paajanen, MD, PhD, Professor of Surgery, University of Eastern Finland, Finland Commencement: 21st of November 2014 Publication of this dissertation is granted by the University of Tartu. ISSN 1024-395X ISBN 978-9949-32-694-5 (print) ISBN 978-9949-32-695-2 (pdf) Copyright: Ceith Nikkolo, 2014 University of Tartu Press www.tyk.ee TABLE OF CONTENTS LIST OF ORIGINAL PUBLICATIONS ....................................................... 7 ABBREVIATIONS ........................................................................................ 8 1. INTRODUCTION ..................................................................................... 9 2. REVIEW OF THE LITERATURE ........................................................... 10 2.1. Definition of inguinal hernia ............................................................. 10 2.2. Etiology of inguinal hernia ................................................................ 11 2.3. Frequency of inguinal hernia ............................................................. 11 2.4. Diagnostics of inguinal hernia ........................................................... 12 2.5. Treatment of inguinal hernia ............................................................. 13 2.5.1. Lichtenstein technique ............................................................. 13 2.5.2. Lichtenstein versus laparoscopic repair .................................. 15 2.6. Classification of inguinal hernias ...................................................... 16 2.7. Meshes used for hernia repair ............................................................ 16 2.8. Hernia recurrence .............................................................................. 20 2.9. Chronic pain after inguinal hernia repair ........................................... 20 2.9.1. Causes of chronic pain ............................................................ 21 2.9.2. Risk factors for development of chronic pain ......................... 22 2.9.3. Assessment of chronic pain ..................................................... 22 2.9.4. Impact of different mesh parameters on chronic pain ............ 23 2.9.5. Surgical treatment of chronic pain .......................................... 25 2.10. Foreign body feeling ........................................................................ 26 2.11. Quality of life ................................................................................... 27 3. AIMS OF THE STUDY ............................................................................ 28 4. MATERIAL AND METHODS ................................................................ 29 4.1. Inclusion and exclusion criteria ......................................................... 29 4.2. Randomisation ................................................................................... 29 4.3. Meshes and operation technique ........................................................ 29 4.3.1. Lightweight versus heavyweight mesh (I, II) .......................... 29 4.3.2. Pore size study (III) ................................................................. 30 4.3.3. Self-gripping versus sutured mesh (IV) .................................. 30 4.4. Preoperative data and follow-up visits .............................................. 31 4.5. Chronic pain ...................................................................................... 31 4.6. Foreign body feeling .......................................................................... 31 4.7. Quality of life .................................................................................... 32 4.8. Statistical analysis ............................................................................. 32 4.8.1. Lightweight versus heavyweight mesh (I, II) .......................... 32 4.8.2. Pore size study (III) ................................................................. 32 4.8.3. Self-gripping versus sutured mesh (IV) .................................. 33 5 5. RESULTS ................................................................................................. 34 5.1. Lightweight versus heavyweight mesh (I, II) .................................... 34 5.2. Pore size study (III) ........................................................................... 42 5.3. Self-gripping versus sutured mesh (IV) ............................................. 48 6. DISCUSSION ........................................................................................... 54 7. CONCLUSIONS ....................................................................................... 63 8. SUMMARY IN ESTONIAN ................................................................... 64 REFERENCES .............................................................................................. 67 ACKNOWLEDGEMENTS .......................................................................... 74 PUBLICATIONS .......................................................................................... 75 CURRICULUM VITAE ............................................................................... 119 ELULOOKIRJELDUS .................................................................................. 120 6 LIST OF ORIGINAL PUBLICATIONS This thesis is based on the following original publications, which are referred to in the text by their Roman numerals: I Nikkolo C, Lepner U, Murruste M, Vaasna T, Seepter H, Tikk T. Rando- mised clinical trial comparing lightweight mesh with heavyweight mesh for inguinal hernioplasty. Hernia 2010;14:253–258 II Nikkolo C, Murruste M, Vaasna T, Seepter H, Tikk T, Lepner U. Three- year results of randomised clinical trial comparing lightweight mesh with heavyweight mesh for inguinal hernioplasty. Hernia 2012;16:555–559 III Nikkolo C, Vaasna T, Murruste M, Seepter H, Kirsimägi Ü, Lepner U. Randomized clinical study evaluating the impact of mesh pore size on chronic pain after Lichtenstein hernioplasty. J Surg Res 2014;191:311– 317 IV Nikkolo C, Vaasna T, Murruste M, Seepter H, Suumann J, Tein A, Kirsimägi Ü, Lepner U. Single-centre single-blinded randomised study of self-gripping versus sutured mesh in open inguinal hernia repair. J Surg Res DOI: 10.1016/j.jss.2014.09.017 Author’s contribution: Conception and study design, data collection, participation in data analysis, writing the papers 7 ABBREVIATIONS BMI body mass index EHS European Hernia Society HW heavyweight mesh ITT intention-to-treat population LW lightweight mesh NSAID non-steroidal anti-inflammatory drug OM, OLP Optilne® LP mesh PP per protocol principle PPG Parietex Progrip™ mesh SF36 Short Form 36 TAPP transabdominal preperitoneal TEP totally extraperitoneal UM Ultrapro® mesh VAS visual analogue scale 8 1. INTRODUCTION In recent decades there has been considerable debate on inguinal hernias – etiology of the disease, indications for surgery, selection of the surgical approach and technique, selection of the prosthetic material and reduction of recurrences and chronic posthernioplasty symptoms. Although the well known and by far the most widely used mesh material polypropylene was developed 60 years ago [Coda et al., 2012; Earle and Mark, 2008] and more than 160 different meshes for hernia repair are in the market [Coda et al., 2012], with millions of prosthetic meshes used worldwide each year [Bay-Nielsen et al., 2001a; Weyhe et al., 2007], we do not yet know the parameters of an ideal mesh [Simons et al., 2009]. After the widely used alloplasty in inguinal hernia surgery, the most common complication is chronic pain whose rates reach 51.6 % [O'Dwyer et al., 2005]. The rate of foreign body feeling occurs in up to 43.8 % of patients after inguinal hernia repair [Post et al., 2004]. Considering the high rate of chronic pain and foreign body feeling after inguinal hernioplasty, which can have major influence on the patients’ quality of life, as well as serious socio-economic impacts, different mesh characteristics should be studied in order to identify the mesh whose usage results in lower rates of long-term pain and foreign body feeling. 9 2. REVIEW OF THE LITERATURE 2.1. Definition of inguinal hernia The musculo-aponeurotic layer of the abdominal wall is formed in order to retain the organs of the abdominal
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