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

Abstract

BackgroundIncisional 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/DesignThis 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.DiscussionTo 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 14th, 2011. An initiation meeting took place in Berlin January 9th, 2012.Trial RegistrationClinicalTrials.gov: NCT01349400

Watchful waiting in incisional hernia: Is it safe?

“…A current, randomized, prospective trial comparing OT with WW in minimally and asymptomatic IH should be awaited before drawing general conclusions. 26 Patients who are treated conservatively should be informed and aware of potential risks of need for emergency repair resulting in greater morbidity and mortality.…”

Watchful Waiting for Ventral Hernias: A Longitudinal Study

“…Such a trial is currently accruing patients in Europe. 6 While waiting results of this, we believe the present study is an important contribution to the literature because of the paucity of published data regarding the natural history of an untreated ventral hernia.…”

“…Currently a multicenter trial comparing WW versus routine repair funded by the German Research Foundation is accruing patients with ''oligosymptomatic'' ventral hernias. 6 Anticipating that results from that trial will not be available for years, we report the results of a prospective longitudinal cohort study of 41 patients with ventral hernias who agreed to WW as their primary treatment strategy.…”

Indikationen zur laparoskopischen Versorgung großer Narbenhernien

“…70% geringer; auch im Vergleich zu Patienten, die kein Netz bekommen haben, scheint die isokinetische Kraft der Bauchdeckenmuskulatur nach Netzimplantation niedriger zu sein [37]. Eine nächste Frage ist die der Lebensqualität bei großen Bruchlücken, welche nicht nur für die Gruppen der offen und laparoskopisch Operierten, sondern auch für eine potenzielle Watchfulwaiting-Gruppe unbekannt ist [38].…”