Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis-the VACOR trial: protocol for a randomised controlled trial

• Published in: World journal of emergency surgery 2022-05, Vol.17 (1), p.25-25, Article 25
• Main Authors: Rajabaleyan, Pooya, Michelsen, Jens, Tange Holst, Uffe, Möller, Sören, Toft, Palle, Luxhøi, Jan, Buyukuslu, Musa, Bohm, Aske Mathias, Borly, Lars, Sandblom, Gabriel, Kobborg, Martin, Aagaard Poulsen, Kristian, Schou Løve, Uffe, Ovesen, Sophie, Grant Sølling, Christoffer, Mørch Søndergaard, Birgitte, Lund Lomholt, Marianne, Ritz Møller, Dorthe, Qvist, Niels, Bremholm Ellebæk, Mark
• Format: Article
• Language: English
• Subjects: Abdomen; Abdominal Cavity - surgery; Care and treatment; Compartment syndrome; Consent; Cytokines; Denmark; Faecal peritonitis; Fistula; Glycerol; Health aspects; Hernia; Hernias; Homeopathy; Hospitalization; Hospitals; Humans; Intensive care; Laparotomy; Laparotomy - adverse effects; Liver diseases; Materia medica and therapeutics; Medicin och hälsovetenskap; Morbidity; Mortality; Multicenter Studies as Topic; Negative-Pressure Wound Therapy - adverse effects; Patients; Peritonitis; Peritonitis - surgery; Postoperative Complications - epidemiology; Primary abdominal closure; Quality of Life; Randomized Controlled Trials as Topic; Relaparotomy on-demand; Reoperation - adverse effects; Secondary peritonitis; Study Protocol; Surgery; Sweden; Therapeutics; Vacuum-assisted closure
• ISSN: 1749-7922; 1749-7922
• DOI: 10.1186/s13017-022-00427-x

Secondary peritonitis is a severe condition with a 20-32% reported mortality. The accepted treatment modalities are vacuum-assisted closure (VAC) or primary closure with relaparotomy on-demand (ROD). However, no randomised controlled trial has been completed to compare the two methods potential benefits and disadvantages. This study will be a randomised controlled multicentre trial, including patients aged 18 years or older with purulent or faecal peritonitis confined to at least 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 within 30 or 90 days and one year after index operation. Secondary outcomes are comprehensive complication index (CCI) and 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 assessed by clinical examination and CT-scanning and healthcare resource utilisation. With an estimated superiority of 15% in the primary outcome for VAC, 340 patients must be included. Hospitals in Denmark and Europe will be invited to participate. 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. The study protocol has been registered at clinicaltrials.gov (NCT03932461). Protocol version 1.0, 9 January 2022.