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Clinical Trials in Denmark / NCT03932461
Recruiting Not applicable

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

NCT03932461 · tracked via the Priya Life Science Denmark tracker
Sponsor
Odense University Hospital
Phase
Not applicable
Started
2020-06-01
Last updated
2023-11-07

Condition(s) studied

Fecal PeritonitisSecondary PeritonitisDiffuse; Peritonitis

Investigational drug(s) / intervention(s)

Vacuum assisted closureRelaparotomy "on demand"

Vacuum assisted closure: 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.

Relaparotomy "on demand": 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.

Study summary

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

Eligibility

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Primary endpoint is to compare peritonitis related complications and Comprehensive Complication Index (CCI) between NPWT treatment (VAC) and conventional treatment (ROD) at 30, 90 days and 1 year. — 1 year
    Disease-Related Major Morbidity Needing Readmission and Conservative Treatment but Not Surgery * Fistula * Wound dehiscence/incisional hernia with obstruction * Abscess needing percutaneous drainage * Renal failure * Myocardial infarction * Gastric or duodenal bleeding * Respiratory failure * Urosepsis Disease-Related Major Morbidity Needing Surgical Intervention During First Admission or Readmission * Incisional hernia * Bowel obstruction or herniation due to intra-abdominal adhesions * Burst abdomen * Abdominal compartment syndrome * Fistula * Intra-abdominal bleeding * Intra-abdominal hematoma needing surgical evacuation * Perforation of visceral organ confirmed at surgery * Anastomotic leakage * Ischemia or necrosis of a visceral organ * Enterostomy dysfunction due to prolapse, stenosis, or retraction * Gastric or duodenal ulcer bleeding needing intervention of any type

Trial sites (1)

FacilityCityRegionStatus
Odense University Hospital Odense Fyn Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03932461 on ClinicalTrials.gov ↗ ← All trials in Denmark