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 - VACOR study group
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
N1 - © 2022. The Author(s).
PY - 2022/5/26
Y1 - 2022/5/26
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 - Abdominal Cavity/surgery
KW - Humans
KW - Laparotomy/adverse effects
KW - Multicenter Studies as Topic
KW - Negative-Pressure Wound Therapy/adverse effects
KW - Peritonitis/surgery
KW - Postoperative Complications/epidemiology
KW - Quality of Life
KW - Randomized Controlled Trials as Topic
KW - Reoperation/adverse effects
KW - Secondary peritonitis
KW - Faecal peritonitis
KW - Relaparotomy on-demand
KW - Vacuum-assisted closure
KW - Primary abdominal closure
U2 - 10.1186/s13017-022-00427-x
DO - 10.1186/s13017-022-00427-x
M3 - Protocol
C2 - 35619144
SN - 1749-7922
VL - 17
SP - 25
JO - World Journal of Emergency Surgery
JF - World Journal of Emergency Surgery
IS - 1
ER -