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Compares treatment options for Fecal Peritonitis
Official title Vacuum Assisted Closure Versus On-demand Relaparotomy in Patients With Fecal or Diffuse Peritonitis
ClinicalTrials.gov ID: NCT03932461
What this study is testing
- What it's testing
- Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis to either vacuum assisted closure or relaparotomy "on-demand".
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older. Healthy volunteers may be eligible.
You may be able to join if
- Patients eligible for enrolment are 18+ years of age and are scheduled for acute laparotomy due to suspected peritonitis originating from perforation...
You likely can't join 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...
- Primary peritonitis
- Immunocompromised (ongoing chemotherapy or prednisolone \>20 mg/day)
- Chronic parenchymal liver disease
- Pregnancy
See the full eligibility 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Odense, Fyn, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Odense, Fyn, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.