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

Rajabaleyan, Pooya LU orcid ; Michelsen, Jens ; Tange Holst, Uffe ; Möller, Sören ; Toft, Palle ; Luxhøi, Jan ; Buyukuslu, Musa ; Bohm, Aske Mathias ; Borly, Lars and Sandblom, Gabriel LU , et al. (2022) In World Journal of Emergency Surgery 17(1).
Abstract

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... (More)

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.

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type
Contribution to journal
publication status
published
subject
keywords
Abdominal Cavity/surgery, Humans, Laparotomy/adverse effects, Multicenter Studies as Topic, Negative-Pressure Wound Therapy/adverse effects, Peritonitis/surgery, Postoperative Complications/epidemiology, Quality of Life, Randomized Controlled Trials as Topic, Reoperation/adverse effects, Phenylurea Compounds
in
World Journal of Emergency Surgery
volume
17
issue
1
article number
25
publisher
BioMed Central (BMC)
external identifiers
  • scopus:85130923948
  • pmid:35619144
ISSN
1749-7922
DOI
10.1186/s13017-022-00427-x
language
English
LU publication?
no
additional info
© 2022. The Author(s).
id
2dc82284-a144-4b1a-84aa-bd4225b34d84
date added to LUP
2026-06-11 16:05:39
date last changed
2026-06-12 04:02:11
@article{2dc82284-a144-4b1a-84aa-bd4225b34d84,
  abstract     = {{<p>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.</p><p>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.</p><p>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.</p><p>TRIAL REGISTRATION: The study protocol has been registered at clinicaltrials.gov (NCT03932461). Protocol version 1.0, 9 January 2022.</p>}},
  author       = {{Rajabaleyan, Pooya and Michelsen, Jens and Tange Holst, Uffe and Möller, Sören and Toft, Palle and Luxhøi, Jan and Buyukuslu, Musa and Bohm, Aske Mathias and Borly, Lars and Sandblom, Gabriel and Kobborg, Martin and Aagaard Poulsen, Kristian and Schou Løve, Uffe and Ovesen, Sophie and Grant Sølling, Christoffer and Mørch Søndergaard, Birgitte and Lund Lomholt, Marianne and Ritz Møller, Dorthe and Qvist, Niels and Bremholm Ellebæk, Mark}},
  issn         = {{1749-7922}},
  keywords     = {{Abdominal Cavity/surgery; Humans; Laparotomy/adverse effects; Multicenter Studies as Topic; Negative-Pressure Wound Therapy/adverse effects; Peritonitis/surgery; Postoperative Complications/epidemiology; Quality of Life; Randomized Controlled Trials as Topic; Reoperation/adverse effects; Phenylurea Compounds}},
  language     = {{eng}},
  month        = {{05}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{World Journal of Emergency Surgery}},
  title        = {{Vacuum-assisted closure versus on-demand relaparotomy in patients with secondary peritonitis-the VACOR trial : protocol for a randomised controlled trial}},
  url          = {{http://dx.doi.org/10.1186/s13017-022-00427-x}},
  doi          = {{10.1186/s13017-022-00427-x}},
  volume       = {{17}},
  year         = {{2022}},
}