Vacuum-Assisted Closure Versus On-demand Relaparotomy in Patients With Secondary Peritonitis – the VACOR Trial: Protocol for a Randomized Controlled Trial

Abstract

Abstract Background Secondary peritonitis is a severe condition with a reported mortality of 20–32%. Vacuum-assisted closure (VAC) or primary closure with relaparotomy on-demand (ROD) are the accepted treatment modalities. However, no randomised controlled trial has been conducted comparing the potential benefits and disadvantages of the two methods. MethodsThis study will be a randomised controlled multicentre trial, including patients aged 18 years or older with purulent or faecal peritonitis confined to up to two of the four abdominal quadrants, originating from the small intestine, colon or rectum. Randomisation will be web-based to either primary closure with ROD or VAC in blocks of 2, 4 and 6. The primary endpoint is peritonitis-related complications and comprehensive Complication Index (CCI) within 30 or 90 days and one year after index operation. Secondary outcomes are mortality after 30 or 90 days and one year; quality of life assessment by (SF-36) after three and 12 months, the development of incisional hernia after 12 months as assessed by clinical examination and CT-scanning and healthcare resource utilisation. With an estimated superiority of 15% in the primary outcome for VAC, a total of 340 patients must be included. Hospitals in Denmark and Europe will be invited to participate.Discussion There is no robust evidence for choosing either open abdomen with VAC-treatment or primary closure with relaparotomy on demand in patients with secondary peritonitis. The present study has the potential to answer this important clinical question.Trial Registration The study protocol has been registered at clinicaltrials.gov (NCT03932461).VersionProtocol version 1.0, 9 January 2022.