Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis
Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis: A Multicenter Randomized Controlled Trial
Odense University Hospital
340 participants
Jun 1, 2020
INTERVENTIONAL
Conditions
Summary
Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis to either vacuum assisted closure or relaparotomy "on-demand".
Eligibility
Inclusion Criteria1
- 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 Criteria13
- 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
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Interventions
The Vacuum assisted closure system consists of an abdominal dressing covering the intra abdominal viscera over the dressing there will be placed a blue sponge which will be covered by drape and connected to a vacuum pump.
Abdomen is closed at the index operation after source of peritonitis is treated. Every 48-hours the patients are evaluated for the need of relaparotomy based on clinical and paraclinical parameters.
Locations(1)
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NCT03932461