The effect of ultrapro or prolene mesh on postoperative pain and well-being following endoscopic Totally Extraperitoneal (TEP) hernia repair (TULP): study protocol for a randomized controlled trial

Trials

Ine PJ Burgmans²  Paul H P Davids²  Egbert-Jan M M Verleisdonk²  Geert Jan Clevers²  Sjoerd G Elias¹  Niels Smakman²  Thijs van Dalen²  Nelleke Schouten³ 

[1] Julius Center for Health Sciences and Primary Care, Utrecht, The Netherlands;Department of Surgery/Hernia Clinic, Diakonessenhuis, Utrecht, The Netherlands;Department of Surgery/Hernia Clinic, Diakonessenhuis, Room: Secretariaat Heelkunde, Professor Lorentzlaan 76, 3707 HL, Zeist, The Netherlands

关键词: Quality of life;    Chronic postoperative pain;    Mesh;    TEP;    Endoscopic hernia repair;   

Others  :  1095551
DOI  :  10.1186/1745-6215-13-76

 received in 2011-07-28, accepted in 2012-06-07,  发布年份 2012

【 摘 要 】

Background

The purpose of this study was to describe the rationale and design of a randomized controlled trial analyzing the effects of mesh type (Ultrapro versus Prolene mesh) on postoperative pain and well-being following an endoscopic Totally Extraperitoneal (TEP) repair for inguinal hernias (short: TULP trial).

Methods and design

The TULP trial is a prospective, two arm, double blind, randomized controlled trial to assess chronic postoperative pain and quality of life following implantation of a lightweight (Ultrapro) and heavyweight (Prolene) mesh in endoscopic TEP hernia repair. The setting is a high-volume single center hospital, specializing in TEP hernia repair. All patients are operated on by one of four surgeons. Adult male patients (≥18 years of age) with primary, reducible, unilateral inguinal hernias and no contraindications for TEP repair are eligible for inclusion in the study. The primary outcome is substantial chronic postoperative pain, defined as moderate to severe pain persisting ≥ 3 months postoperatively (Numerical Rating Scale, NRS 4–10). Secondary endpoints are the individual development of pain until three years after the TEP procedure, the quality of life (QoL), recurrence rate, patient satisfaction and complications.

Discussion

Large prospective randomized controlled studies with a long follow-up evaluating the incidence of chronic postoperative pain following implantation of lightweight and heavyweight mesh in endoscopic (TEP) hernia repair are limited. By studying the presence of pain and quality of life, but also complications and recurrences in a large patient population, a complete efficiency and feasibility assessment of both mesh types in TEP hernia repair will be performed.

Trial registration

The TULP study is registered in the Dutch Trial Register (NTR2131)

【 授权许可】

   
2012 Schouten et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Simons MP, de Lange D, Beets GL, van Geldere D, Heij HA, P.M.N.Y.H Go: Richtlijn Liesbreuk van de Nederlandse Verenigning voor Heelkunde. http://www.ntvg.nl/publicatie/richtlijn-liesbreuk-van-de-nederlandse-/volledig webcite
• [2]Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikinnen T, Kingsnorth A, Kukleta J, Morales-Conde S, Nordin P, Schumpelick V, Smedberg S, Smietanski M, Weber G, Miserez M: European Hernia Society guidelines on the treatment of inguinal hernia in adult patients. Hernia 2009, 13:343-403.
• [3]Ferzli GS, Edwards ED, Khoury GE: Chronic pain after inguinal herniorrhaphy. J Am Coll Surg 2007, 205:333-341.
• [4]Matthews RD, Neumayer L: Inguinal hernia in the 21st century: an evidence-based review. Curr Probl Surg 2008, 45:261-312.
• [5]Bozuk M, Schuster R, Stewart D, Hicks K, Greaney G, Waxman K: Disability and chronic pain after open mesh and laparoscopic inguinal hernia repair. Am Surg 2003, 69:839-841.
• [6]Kuhry E, van Veen RN, Langeveld HR, Steyerberg EW, Jeekel J, Bonjer HJ: Open or endoscopic total extraperitoneal inguinal hernia repair. A systematic review. Surg Endosc 2007, 21:161-166.
• [7]National Institute for Clinical Excellence (NICE): Laparoscopic Surgery for Inguinal Hernia Repair. , ; . http://www.nice.org.uk/nicemedia/pdf/TA083guidance.pdf webcite
• [8]Wake BL, McCormack K, Fraser C, Vale L, Perez J, Grant AM: Transabdominal pre-peritoneal (TAPP) vs totally extraperitoneal (TEP) laparoscopic techniques for inguinal hernia repair. Cochrane Database Syst Rev 2005, 1:CD004703.
• [9]Bringman S, Wollert S, Osterberg J, Smedberg S, Granlund H, Heikkinen TJ: Three-year results of a randomized clinical trial of lightweight or standard polypropylene mesh in Lichtenstein repair of primary inguinal hernia. Br J Surg 2005, 93:1056-1059.
• [10]Lauscher JC, Yafaei K, Buhr HJ, Ritz JP: Total Extraperitoneal Hernioplasty: Does the Long-Term Clinical Course Depend on the Type of Mesh? J Laparoendosc Adv Surg Tech A 2008, 18:803-808.
• [11]Bringman S, Wollert S, Osterberg J, Heikkinen T: Early results of a randomized multicenter trial comparing Prolene and VyproII mesh in bilateral endoscopic extraperitoneal hernioplast (TEP). Surg Endosc 2005, 19:536-540.
• [12]Agarwal BB, Agarwal KA, Mahajan KC: Prospective double-blind randomized controlled study comparing heavy- and lightweight polypropylene mesh in totally extraperitoneal repair of inguinal hernia: early results. Surg Endosc 2009, 23:242-247.
• [13]Klosterhalfen B, Klinge U, Rosch R, Junge K: Long-term inertness of meshes. In Meshes: Benefits and Risks. Edited by Schumpelick V, Nyhus L. Springer-Verlag, Berlin; 2003.
• [14]Klosterhalfen B, Junge K, Klinge U: The lightweight and large porous mesh concept for hernia repair. Expert Rev Med Devices 2005, 2:103-117.
• [15]Akolekar D, Kumar S, Khan LR, de Beaux AC, Nixon SJ: Comparison of recurrence with lightweight composite polypropylene mesh and heavyweight mesh in laparoscopic totally extraperitoneal inguinal hernia repair: an audit of 1232 repairs. Hernia 2008, 12:39-43.
• [16]Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG: CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. Int J Surg. 2012, 10:28-55.
• [17]Lau H, Patil NG, Yuen WK: Day-case endoscopic totally extraperitoneal inguinal hernioplasty versus open Lichtenstein hernioplasty for unilateral primary inguinal hernia in males: a randomized trial. Surg Endosc 2006, 20:76-81.
• [18]Fränneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyrén O, Sandblom G: Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg 2008, 95:488-493.
• [19]Daut RL, Cleeland CS, Flanery RC: The development of the Wisconsin Brief Pain Questionnaire to assess pain in cancer and other diseases. Pain 1983, 17:197-210.
• [20]Cleeland CS, Ryan KM: Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singapore 1994, 23:129-138.
• [21]Heniford BT, Walters AL, Lincourt AE, Novitsky YW, Hope WW, Kercher KW: Comparison of generic versus specific quality-of-life scales for mesh hernia repairs. J Am Coll Surg 2008, 206:638-644.
• [22]Aaronson NK, Muller M, Cohen PD: Translation, validation, and norming of the Dutch language version of the SF-36 Health Survey in community and chronic disease populations. J Clin Epidemiol 1998, 51:1055-1068.
• [23]The EuroQol Group: EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990, 16:199-208.
• [24]Aasvang EK, Møhl B, Bay-Nielsen M, Kehlet H: Pain related sexual dysfunction after inguinal herniorrhaphy. Pain 2006, 122:258-263.
• [25]Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A: The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology 1997, 49:822-830.
• [26]Loos MJA, Roumen RMH, Scheltinga MRM: Classifying Postherniorrhaphy Pain Syndromes Following Elective Inguinal Hernia Repair. World J Surg 2007, 31:1760-1765.
• [27]Kalliomäki ML, Meyerson J, Gunnarsson U, Gordh T, Sandblom G: Long-term pain after inguinal hernia repair in a population-based cohort; risk factors and interference with daily activities. Eur J Pain 2008, 12:214-225.