Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis

Recruiting now · Not applicable

Conditions studied: Fecal Peritonitis, Secondary Peritonitis, Diffuse; Peritonitis

In brief

Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis to either vacuum assisted closure or relaparotomy "on-demand".

Key facts

Study ID

NCT03932461

Run by

Odense University Hospital

People needed

340

Starts

2020-06-01

Expected to finish

2027-09-01

Last updated by the study team

2023-11-07

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Odense University Hospital — Odense, Fyn, Denmark (enrolling)

Full record on ClinicalTrials.gov

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