Comparing vacuum assisted closure and on-demand relaparotomy for fecal peritonitis
Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis: A Multicenter Randomized Controlled Trial
This study is testing whether using vacuum assisted closure or doing surgery as needed is better for patients with fecal peritonitis in terms of recovery and complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Odense University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Odense, Fyn) |
| Trial ID | NCT03932461 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 scheduled for acute laparotomy due to suspected diffuse peritonitis from perforation of the small bowel, colon, or rectum.
Not a fit: Patients with peritonitis from sources other than the small intestine, colon, or rectum, or those with certain comorbidities, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced complications for patients with fecal peritonitis.
How similar studies have performed: Other studies have explored similar interventions, but this specific comparison of VAC and ROD in the context of fecal peritonitis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Odense, Fyn
- Odense University Hospital — Odense, Fyn, Denmark (Recruiting)
Study contacts
- Study coordinator: Pooya Rajabaleyan, M.D.
- Email: pooya.r@hotmail.com
- Phone: +4527118889
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.