TY - JOUR

T1 - Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis-the VACOR trial

T2 - protocol for a randomised controlled trial

AU - Rajabaleyan, Pooya

AU - Michelsen, Jens

AU - Tange Holst, Uffe

AU - Möller, Sören

AU - Toft, Palle

AU - Luxhøi, Jan

AU - Buyukuslu, Musa

AU - Bohm, Aske Mathias

AU - Borly, Lars

AU - Sandblom, Gabriel

AU - Kobborg, Martin

AU - Aagaard Poulsen, Kristian

AU - Schou Løve, Uffe

AU - Ovesen, Sophie

AU - Grant Sølling, Christoffer

AU - Mørch Søndergaard, Birgitte

AU - Lund Lomholt, Marianne

AU - Ritz Møller, Dorthe

AU - Qvist, Niels

AU - Bremholm Ellebæk, Mark

AU - VACOR study group

N1 - Publisher Copyright: © 2022. The Author(s).

PY - 2022

Y1 - 2022

N2 - BACKGROUND: 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. METHODS: 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. 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). Protocol version 1.0, 9 January 2022.

AB - BACKGROUND: 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. METHODS: 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. 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). Protocol version 1.0, 9 January 2022.

KW - Faecal peritonitis

KW - Primary abdominal closure

KW - Relaparotomy on-demand

KW - Secondary peritonitis

KW - Vacuum-assisted closure

U2 - 10.1186/s13017-022-00427-x

DO - 10.1186/s13017-022-00427-x

M3 - Journal article

C2 - 35619144

AN - SCOPUS:85130923948

VL - 17

JO - World Journal of Emergency Surgery

JF - World Journal of Emergency Surgery

SN - 1749-7922

M1 - 25

ER -