Study protocol for a randomized controlled trial for anterior inguinal hernia repair: transrectus sheath preperitoneal mesh repair compared to transinguinal preperitoneal procedure

Trials

Cees JHM van Laarhoven³  Willem L Akkersdijk⁴  Roland MHG Mollen²  Patrick WHE Vriens¹  Eric F Keus³  Giel G Koning³  M Wiesje Prins³ 

[1] TweeSteden Hospital, Kasteellaan 2, 5141 BM, Waalwijk, The Netherlands;Gelderse Vallei Hospital, Willy Brandtlaan 10, 6716 RP, Ede, The Netherlands;Department of Surgery, Radboud University Nijmegen Medical Centre, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, Gelderland, The Netherlands;St Jansdal Hospital, Wethouder Jansenlaan 90, 3844 DG, Harderwijk, The Netherlands

关键词: Randomized;    Trial;    Open repair;    TIPP;    TREPP;    Mesh;    Preperitoneal;    Hernia;    Inguinal;    Chronic pain;   

Others  :  1094613
DOI  :  10.1186/1745-6215-14-65

 received in 2012-08-08, accepted in 2013-02-12,  发布年份 2013

【 摘 要 】

Background

Anterior open treatment of the inguinal hernia with a tension-free mesh has reduced the incidence of hernia recurrence. The Lichtenstein procedure is the current reference technique for inguinal hernia treatment. Chronic pain has become the main postoperative complication after surgical inguinal hernia repair, especially following Lichtenstein. Preliminary experiences with a soft mesh positioned in the preperitoneal space (PPS) by transinguinal preperitoneal (TIPP) or total extraperitoneal (TEP) technique, showed promising results considering the reduction of postoperative chronic pain. Evolution of surgical innovations for inguinal hernia repair led to an open, direct approach with preperitoneal mesh position, such as TIPP. Based on the TIPP procedure, another preperitoneal repair has been recently developed, the transrectus sheath preperitoneal (TREPP) mesh repair.

Methods

The ENTREPPMENT trial is a multicentre randomized clinical trial. Patients will be randomly allocated to anterior inguinal hernia repair according to the TREPP mesh repair or TIPP procedure. All patients with a primary unilateral inguinal hernia, eligible for operation, will be invited to participate in the trial. The primary outcome measure will be the number of patients with postoperative chronic pain. Secondary outcome measures will be serious adverse events (SAEs), including recurrence, hemorrhage, return to daily activities (for example work), operative time and hospital stay. Alongside the trial health status, an economic evaluation will be performed. To demonstrate that inguinal hernia repair according to the TREPP technique reduces the percentage of patients with postoperative chronic pain from 12% to <6%, a sample size of 800 patients is required (two-sided test, α = 0.05, 80% power).The ENTREPPMENT trial aims to evaluate the TREPP and TIPP procedures from patients’ perspective. It is hypothesized that the TREPP technique may reduce the number of patients with any form of postoperative chronic pain by 50% compared to the TIPP procedure.

Trial registration

Current Controlled Trials: ISRCTN18591339

【 授权许可】

   
2013 Prins et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Statline: Centraal Bureau voor de Statistiek. http://statline.cbs.nl webcite
• [2]McCormack K, Scott NW, Go PM, Ross S, Grant AM: Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev 2003, 1:CD001785.
• [3]Franneby U, Sandblom G, Nordin P, Nyren O, Gunnarsson U: Risk factors for long-term pain after hernia surgery. Ann Surg 2006, 244(2):212-219.
• [4]Bay-Nielsen M, Perkins FM, Kehlet H: Pain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study. Ann Surg 2001, 233(1):1-7.
• [5]Poobalan AS, Bruce J, King PM, Chambers WA, Krukowski ZH, Smith WC: Chronic pain and quality of life following open inguinal hernia repair. Br J Surg 2001, 88(8):1122-1126.
• [6]The ‘Inguinal hernia’ guideline of the Association of Surgeons of the Netherlands 2003. http://www.heelkunde.nl webcite
• [7]Bay-Nielsen M, Nilsson E, Nordin P, Kehlet H: Chronic pain after open mesh and sutured repair of indirect inguinal hernia in young males. Br J Surg 2004, 91(10):1372-1376.
• [8]Köninger J, Redecke J, Butters M: Chronic pain after hernia repair: a randomized trial comparing Shouldice, Lichtenstein and TAPP. Langenbecks Arch Surg 2004, 389(5):361-365.
• [9]Pélissier EP, Blum D, Marre P, Damas JM: Inguinal hernia: a patch covering only the myopectineal orifice is effective. Hernia 2001, 5(2):84-87.
• [10]Pélissier EP: Inguinal hernia: preperitoneal placement of a memory-ring patch by anterior approach. Preliminary experience. Hernia 2006, 10(3):248-252.
• [11]Koning GG, Keus F, Koeslag L, Cheung CL, Avçi M, van Laarhoven CJHM, Vriens PWHE: Randomized clinical trial of chronic pain after the transinguinal preperitoneal technique compared with Lichtenstein's method for inguinal hernia repair. Br J Surg 2012, 99(10):1365-1373.
• [12]Koning GG, Andeweg CS, Keus F, van Tilburg MWA, van Laarhoven CJHM, Akkersdijk WL: The transrectus sheath preperitoneal mesh repair for inguinal hernia: technique, rationale and results of the first 50 cases. Hernia 2012, 16(3):295-299.
• [13]Reinpold WM, Nehls J, Eggert A: Nerve management and chronic pain after open inguinal hernia repair: a prospective two phase study. Ann Surg 2011, 254(1):163-168.
• [14]Keus F, Wetterslev J, Gluud C, van Laarhoven CJ: Evidence at a glance: error matrix approach for overviewing available evidence. BMC Med Res Methodol 2010, 10:90.
• [15]Guyatt GH, Oxman AD, Kunz R, Vist GE, Falck-Ytter Y, Schünemann HJ, GRADE Working Group: What is "quality of evidence" and why is it important to clinicians? BMJ 2008, 336(7651):995-998.
• [16]Wood L, Egger M, Gluud LL, Schulz KF, Jüni P, Altman DG, Gluud C, Martin RM, Wood AJ, Sterne JA: Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ 2008, 336(7644):601-605.
• [17]Central Committee on Research Involving Human Subjects: The Hague. Independent Review Board Nijmegen; http://www.ccmo-online.nl webcite
• [18]Koning GG, de Schipper HJ, Oostvogel HJ, Verhofstad MH, Gerritsen PG, van Laarhoven CJHM, Vriens PW: The Tilburg double blind randomised controlled trial comparing inguinal hernia repair according to Lichtenstein and the transinguinal preperitoneal technique. Trials 2009, 10:89.
• [19]Classification of chronic pain. Descriptions of chronic pain syndromes and definitions of pain terms. Prepared by the International Association for the study of pain, subcommittee on taxonomy Pain Suppl 1986, 3:S1-S226. 3
• [20]Miserez M, Alexandre JH, Campanelli G, Corcione F, Cuccurullo D, Pascual MH, Hoeferlin A, Kingsnorth AN, Mandala V, Palot JP, Schumpelick V, Simmermacher RK, Stoppa R, Flament JB: The European hernia society groin hernia classification: simple and easy to remember. Hernia 2007, 11(2):113-116.
• [21]Ducic I, Moxley M, Al-Attar A: Algorithm for treatment of postoperative incisional groin pain after cesarean delivery or hysterectomy. Obstet Gynecol 2006, 108(1):27-31.
• [22]WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects http://www.wma.net/en/30publications/10policies/b3 webcite
• [23]Schulz KF, Altman DG, Moher D, CONSORT Group: CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010, 340:c332.