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Prevention of Hernia After Loop Ileostomy Reversal

Study acronym: PHaLIR
StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Minor 2 versions Re-verified since Mar 8, 2024, no change to tracked fieldsv8-v9
  2. Notable Primary completion date: Dec 31, 2022 to Dec 31, 2026
    • Study sites: 3 to 4
    • Study completion date: Dec 31, 2023 to Dec 31, 2029
    v7
  3. Notable Primary completion date: Dec 31, 2021 to Dec 31, 2022v6
  4. Notable Primary completion date: Dec 31, 2020 to Dec 31, 2021v5
  5. Notable Primary completion date: Feb 28, 2020 to Dec 31, 2020
    • Study completion date: Feb 28, 2023 to Dec 31, 2023
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv3
  2. Minor Secondary endpoints: details revised at 1 of 5 entries
    • Study description shortened, about 9 words
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
PHaLIR is a prospective, double-blinded randomized study in which patients planned for stoma reversal after rectal cancer surgery are randomized between retro muscular mesh Ultrapro Advanced or standard treatment without mesh.
Trial Details
NCT Number NCT03720262
Lead Sponsor Karolinska Institutet
Collaborators: Stockholm South General Hospital
Conditions
(from sponsor)
Loop Ileostomy
Enrollment 208 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov