NCT03932461 Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis
| NCT ID | NCT03932461 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Odense University Hospital |
| Condition | Fecal Peritonitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 340 participants |
| Start Date | 2020-06-01 |
| Primary Completion | 2024-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 340 participants in total. It began in 2020-06-01 with a primary completion date of 2024-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Niels Qvist, Professor
STUDY DIRECTOR
Surgical Department A, Odense University Hospital, Denmark
Frequently Asked Questions
Who can join the NCT03932461 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Fecal Peritonitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03932461 currently recruiting?
Yes, NCT03932461 is actively recruiting participants. Contact the research team at pooya.r@hotmail.com for enrollment information.
Where is the NCT03932461 trial being conducted?
This trial is being conducted at Odense, Denmark.
Who is sponsoring the NCT03932461 clinical trial?
NCT03932461 is sponsored by Odense University Hospital. The principal investigator is Niels Qvist, Professor at Surgical Department A, Odense University Hospital, Denmark. The trial plans to enroll 340 participants.