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PRELOOP Trial: Synthetic Versus Biological Mesh for Prevention of Incisional Hernia After Loop-ileostomy Closure

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Primary completion date changed from estimate of Oct 2022 to Oct 30, 2022v14
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 4 of 4 sites
    v13
  3. Primary completion date: May 2021 to Oct 2022
    • Study completion date: Mar 2025 to Oct 2027
    v12
  4. Primary completion date: Mar 2021 to May 2021v11
  5. Primary completion date: Mar 2020 to Mar 2021v10
Show 8 earlier versionsHide 8 earlier versions
  1. Study sites: 5 to 4
    • Eligibility criteria shortened, about 20 words
    v9
  2. Re-verified, no change to tracked fieldsv8
  3. Study sites: 6 to 5v7
  4. Secondary endpoints revised (7)v6
  5. Site details revised at 1 of 6 sitesv5
  6. Site details revised at 1 of 6 sitesv4
  7. Study sites: 7 to 6v3
  8. Site details revised at 1 of 7 sitesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This study compares a synthetic mesh and biological implant in prevention of incisional hernia after loop-ileostomy closure.
Trial Details
NCT Number NCT03445936
Lead Sponsor University of Oulu
Conditions
(from sponsor)		 Rectum Cancer
Related terms Rectal Neoplasms
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov