Development of a clinical trial to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia: study protocol for a randomized controlled trial

Trials

Jörg-Peter Ritz⁴  Heinz J Buhr⁴  Ralf Hammerich⁵  Uwe Behrens¹  Jens Neudecker²  Andrea Stroux³  Peter Martus³  Johannes C Lauscher⁴ 

[1] Coordinating Center for Clinical Studies, Charité Campus Virchow Klinikum, Augustenburger Platz 1, 13353 Berlin, Charité Campus Mitte, Hindenburgdamm 30, 12200 Berlin, Germany;Department of General, Viszeral, and Thoracic Surgery, Charité Campus Mitte, Chirurgie, Germany;Institute of Biometry and Clinical Epidemiology, Charité Campus Mitte, Charitéplatz 1, 10117 Berlin, Germany;Department of General, Vascular, and Thoracic Surgery, Charité Campus Benjamin Franklin, Hindenburgdamm 30, 12200 Berlin, Germany;Division of Medical Controlling, Charité Campus Mitte, Charitéplatz 1, 10117 Berlin, Germany

关键词: prospective randomized trial;    surgical repair;    watchful waiting;    oligosymptomatic incisional hernia;   

Others  :  1095686
DOI  :  10.1186/1745-6215-13-14

 received in 2011-09-01, accepted in 2012-02-07,  发布年份 2012

【 摘 要 】

Background

Incisional hernia is a frequent complication in abdominal surgery. This article describes the development of a prospective randomized clinical trial designed to determine whether watchful waiting is an acceptable alternative to surgical repair for patients with oligosymptomatic incisional hernia.

Methods/Design

This clinical multicenter trial has been designed to compare watchful waiting and surgical repair for patients with oligosymptomatic incisional hernia. Participants are randomized to watchful waiting or surgery and followed up for two years. The primary efficacy endpoint is pain/discomfort during normal activities as a result of the hernia or hernia repair two years after enrolment, as measured by the hernia-specific Surgical Pain Scales (SPS). The target sample size of six hundred thirty-six patients was calculated to detect non-inferiority of the experimental intervention (watchful waiting) in the primary endpoint. Sixteen surgical centers will take part in the study and have submitted their declaration of commitment giving the estimated number of participating patients per year. A three-person data safety monitoring board will meet annually to monitor and supervise the trial.

Discussion

To date, we could find no published data on the natural course of incisional hernias. To our knowledge, watchful waiting has never been compared to standard surgical repair as a treatment option for incisional hernias. A trial to compare the outcome of the two approaches in patients with oligosymptomatic incisional hernias is urgently needed to provide data that can facilitate the choice between treatment options. If watchful waiting was equal to surgical repair, the high costs of surgical repair could be saved. The design for such a trial is described here.

This multicenter trial will be funded by the German Research Foundation (DFG). The ethics committee of the Charité has approved the study protocol. Approval has been obtained from ten study sites at time of this submission. The electronic Case Report Forms have been created. The first patient was to be randomized November 14^th, 2011. An initiation meeting took place in Berlin January 9^th, 2012.

Trial Registration

ClinicalTrials.gov: NCT01349400

【 授权许可】

   
2012 Lauscher et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Seiler CM, Bruckner T, Diener MK, Papyan A, Golcher H, Seidlmayer C, Franck A, Kieser M, Büchler MW, Knaebel HP: Interrupted or continuous slowly absorbable sutures for closure of primary elective midline abdominal incisions: a multicenter randomized trial (INSECT: ISRCTN24023541). Ann Surg 2009, 249:576-82.
• [2]InEk [http://www.g-drg.de/cms/] webcite 2009. Website accessed on October 20, 2011
• [3]Bisgaard T, Kehlet H, Bay-Nielsen MB, Iversen MG, Wara P, Rosenberg J, Friis-Andersen HF, Jorgensen LN: Nationwide study of early outcomes after incisional hernia repair. Br J Surg 2009, 96(12):1452-7.
• [4]Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J: Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg 2004, 240:578-83.
• [5]Altom LK, Snyder CW, Gray SH, Graham LA, Vick CC, Hawn MT: Outcomes of emergent incisional hernia repair. Am Surg 2011, 77:971-6.
• [6]Read RC, Yoder G: Recent trends in the management of incisional herniation. Arch Surg 1989, 124(4):85-8.
• [7]Manninen MJ, Lavonius M, Perhoniemi VJ: Results of incisional hernia repair. A retrospective study of 172 unselected hernioplasties. Eur J Surg 1991, 157:29-31.
• [8]Courtney CA, Lee AC, Wilson C, O'Dwyer PJ: Ventral hernia repair: a study of current practice. Hernia 2003, 7(1):44-6.
• [9]Nieuwenhuizen J, Halm JA, Jeekel J, Lange JF: Natural course of incisional hernia and indications for repair. Scand J of Surg 2007, 96:293-6.
• [10]Lauscher JC, Rieck S, Loh JC, Gröne J, Buhr HJ, Ritz JP: Oligosymptomatic vs. symptomatic incisional hernias-who benefits from open repair? Langenbecks Arch Surg 2011, 396(2):179-85.
• [11]Fitzgibbons RJ Jr, Giobbie-Hurder A, Gibbs JO, Dunlop DD, Reda DJ, McCarthy M Jr, Neumayer LA, Barkun JS, Hoehn JL, Murphy JT, Sarosi GA Jr, Syme WC, Thompson JS, Wang J, Jonasson O: Watchful waiting vs repair of inguinal hernia in minimally symptomatic men: a randomized clinical trail. JAMA 2006, 295(1):285-92.
• [12]Gibbs JO, Giobbie-Hurder A, Edelman P, McCarthy M Jr, Fitzgibbons RJ Jr: Does delaying repair of an asymptomatic hernia have a penalty? Am J Surg 2008, 195:89-93.
• [13]Stroupe KT, Manheim LM, Luo P, Giobbie-Hurder A, Hynes DM, Jonasson O, Reda DJ, Gibbs JO, Dunlop DD, Fitzgibbons RJ Jr: Tension-free repair versus watchful waiting for men with asymptomatic or minimally symptomatic inguinal hernias: a cost-effectiveness analysis. J Am Coll Surg 2006, 203(4):458-68.
• [14]Simons MP, Aufenacker T, Bay-Nielsen M, Bouillot JL, Campanelli G, Conze J, de Lange D, Fortelny R, Heikkinen 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.
• [15]Nieuwenhuizen J, Kleinrensink GJ, Hop WC, Jeekel J, Lange JF: Indications for incisional hernia repair: an international questionnaire among hernia surgeons. Hernia 2008, 12(3):223-5.
• [16]Lauscher JC, Yafaei K, Buhr HJ, Ritz JP: Pain and dysesthesia following total extraperitoneal hernia repair. Chirurg 2009, 80:956-65. (German)
• [17]McCarthy M Jr, Chang CH, Pickard AS, Giobbie-Hurder A, Price DD, Jonasson O, Gibbs J, Fitzgibbons R, Neumayer L: Visual analog scales for assessing surgical pain. J Am Coll Surg 2005, 201(2):245-52.
• [18]Garbe E, Röhmel J, Gundert-Remy U: Clinical and statistical issues in therapeutic equivalence trials. Eur J Clin Pharmacol 1993, 45:1-7.
• [19]Kilian M, Hammerich R, Langelotz C, Raue W, Tsilimparis N, Rau B, Hartmann J: [Hyperthermic intraperitoneal chemotherapy in the German DRG system. Chirurg 2010, 81(11):1005-12. (German)
• [20]Dillmann U, Nilges P, Saile H, Gerbershagen HU: Assessing disability in chronic pain patients. Schmerz 1994, 8(2):100-10. (German)
• [21]Mewes R, Rief W, Stenzel N, Glaesmer H, Martin A, Brähler E: What is "normal" disability? An investigation of disability in the general population. Pain 2009, 142(1-2):36-41.
• [22]Bullinger M, Mohrfeld M: The SF-36 Health Survey. Health economics evaluations. 2007, 387-402. C, (German)
• [23]Herrmann C: International experiences with the Hospital Anxiety and Depression Scale-a review of validation data and clinical results. J Psychosom Res 1997, 42(1):17-41.
• [24]Fitzgibbons RJ Jr, Jonasson O, Gibbs J, Dunlop DD, Henderson W, Reda D, Giobbie-Hurder A, McCarthy M: The Development of a Clinical Trial to determine if watchful waiting is an acceptable alternative to routine herniorrhaphy for patients with minimal or no hernia symptoms. J Am Coll Surg 2003, 196(5):737-42.
• [25]Schulz KF, Altman DG, Moher D, the CONSORT Group: CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials 2010, 11:32. BioMed Central Full Text
• [26]Mayo WJ: An operation for the radical cure of umbilical hernia. Ann Surg 1901, 34:276-80.
• [27]Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG: CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol 1992, 13(10):606-8.
• [28]Dietz UA, Spor L, Germer CT: Management of mesh-related infections. Chirurg 2011, 82(3):208-17. (German)
• [29]Levy MM, Fink MP, Marshall JC, Abraham E, Angus D, Cook D, Cohen J, Opal SM, Vincent JL, Ramsay G, SCCM/ESICM/ACCP/ATS/SIS: 2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med 2003, 31(4):1250-6.