Comparing vacuum assisted closure and on-demand relaparotomy for fecal peritonitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter randomized controlled trial aims to compare the effectiveness of vacuum assisted closure (VAC) versus on-demand relaparotomy (ROD) in patients suffering from fecal or diffuse peritonitis. The study will assess postoperative complications and the Comprehensive Complication Index (CCI) at multiple time points, including 30 days, 90 days, and 1 year post-surgery. Secondary outcomes will include mortality rates, SOFA scores, quality of life assessments, and ventral hernia occurrences. A total of 340 patients will be enrolled to ensure robust data collection and analysis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients eligible for enrolment are 18+ years of age and are scheduled for acute laparotomy due to suspected peritonitis originating from perforation of the small bowel, colon, or rectum. To be included, purulent, enteric, or fecal contamination in a minimum of 2 out of 4 quadrants must be confirmed.

Exclusion Criteria:

* Diffuse peritonitis originating from a different focus than the small intestine, colon or rectum
* Diffuse peritonitis originating from a perforation on the stomach, duodenum, gallbladder, appendix, necrotizing pancreatitis, salpingitis, or peritoneal dialysis
* Primary peritonitis
* Immunocompromised (ongoing chemotherapy or prednisolone \>20 mg/day)
* Chronic parenchymal liver disease
* Pregnancy
* Patients with end-stage disease
* Laparoscopic surgery (not converted to laparotomy)
* Acute occlusion of superior mesenteric artery
* Peritoneal carcinomatosis
* Abdominal trauma
* Lack of consent from the surgical equipoise
* Local peritonitis confined to 1 quadrant only

Where it's running

• Odense University Hospital
  Odense, Fyn, Denmark Recruiting

Study contacts

• Study coordinator: Pooya Rajabaleyan, M.D.
• Email: pooya.r@hotmail.com
• Phone: +4527118889

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.