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

Study acronym: VACOR
StatusRecruiting
PhaseNot applicable
Started

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Trial flagged as At Risk
Primary completion moved at least 6 years later Sep 1, 2024 → Sep 1, 2030
See other at-risk trials from Odense University Hospital

Record History

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  1. Primary completion pushed from Sep 1, 2024 to Sep 1, 2030 Show 6 more changesShow less
    • Study completion pushed from Sep 1, 2027 to Sep 1, 2030
    • Interventions: Relaparotomy "on demand" (Procedure), Vacuum assisted closure (Procedure) to Relaparotomy "on demand" (Procedure), Vacuum assisted closure (Procedure)
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description expanded, about 13 words
    • Publications: details revised at 1 of 1 entry
  2. Primary completion date: Sep 1, 2023 to Sep 1, 2024
    • Study completion date: Sep 1, 2024 to Sep 1, 2027
    v5
  3. Enrollment target: 320 to 340
    • Eligibility criteria shortened, about 51 words
    • Secondary endpoints revised (4)
    • Study description shortened, about 529 words
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 8 more changesShow less
    • Primary completion date: Sep 1, 2022 to Sep 1, 2023
    • Start date changed from estimate of Sep 1, 2019 to Jun 1, 2020
    • Primary endpoint revised
    • Study completion date: Sep 1, 2023 to Sep 1, 2024
    • Eligibility criteria expanded, about 159 words
    • Secondary endpoints: 3 to 4
    • Study description expanded, about 2,391 words
    • Site details revised
  5. Secondary endpoints: details revised at 1 of 3 entriesv2
  6. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Multicenter randomized controlled trial including patients with fecal or diffuse peritonitis to either vacuum assisted closure or relaparotomy "on-demand".
Trial Details
NCT Number NCT03932461
Lead Sponsor Odense University Hospital
Conditions
(from sponsor)		 Fecal Peritonitis, Secondary Peritonitis, Diffuse; Peritonitis
Related terms Peritonitis
Enrollment 340 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov