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NCT03932461
Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis
Conditions: Fecal Peritonitis, Secondary Peritonitis, Diffuse; Peritonitis
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 340
Sponsor: Odense University Hospital
Location: Odense University Hospital Odense Fyn
Summary
Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis to either vacuum assisted closure or relaparotomy "on-demand".
Eligibility 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
Source: ClinicalTrials.gov (NCT03932461). StuddyBuddy aggregates publicly available trial information.