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

NCT03932461 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2023-11-07

No results posted yet for this study

Summary

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

Conditions

  • Fecal Peritonitis
  • Secondary Peritonitis
  • Diffuse; Peritonitis

Interventions

PROCEDURE

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.

PROCEDURE

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.

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Principal Investigators

  • Niels Qvist, Professor · Surgical Department A, Odense University Hospital, Denmark

  • Uffe Tange Holst, M.D. · Surgical Department A, Odense University Hospital, Denmark

  • Jens Michelsen, M.D. · Anesthesiology department V, Odense University Hospital, Denmark

  • Palle Toft, Professor · Anesthesiology department V, Odense University Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2024-09-01
Completion
2027-09-01
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03932461 on ClinicalTrials.gov