The clinical effects of closure of the hernia gap after laparoscopic ventral hernia repair: protocol for a randomised controlled trial.

INTRODUCTION: Closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair. Beneficial effects of this technique have been reported sporadically, but no evidence is available from randomised controlled trials. The primary purpose of this paper is to compare early post-operative activity-related pain in patients undergoing laparoscopic ventral hernia repair with closure of the gap with patients undergoing standard laparoscopic ventral hernia repair (non-closure of the gap). Secondary outcomes are patient-rated cosmesis and hernia-specific quality of life.
METHODS: A randomised, controlled, double-blinded study is planned. Based on power calculation, we will include 40 patients in each arm. Patients undergoing elective laparoscopic umbilical, epigastric or umbilical trocar-site hernia repair at Hvidovre Hospital and Herlev Hospital, Denmark, are invited to participate.
CONCLUSION: The gap closure technique may induce more post-operative pain than the non-closure repair, but it may also be superior with regard to other important surgical outcomes. No studies have previously investigated closure of the gap in the setting of a randomised controlled trial. FUNDING: The study is funded by The University of Copenhagen and private foundations. TRIAL REGISTRATION: NCT01962480 (clinicaltrials.gov).

RCT Entities:   Population Interventions Outcomes