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Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated February 1, 2024 (before its estimated February 3, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Feb 3, 2023 to Feb 3, 2025v12
  2. Primary completion date: Mar 2022 to Feb 3, 2023v11 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 244 to confirmed 109
    • Study completion date: Mar 2027 to Mar 2028
    • Site details revised at 7 of 7 sites
  3. Re-verified, no change to tracked fieldsv10
  4. Site details revised at 1 of 7 sitesv9
  5. Study sites: 8 to 7v8
Show 6 earlier versionsHide 6 earlier versions
  1. Site details revised at 1 of 8 sitesv7
  2. Eligibility criteria revised
    • Site details revised at 1 of 8 sites
    v6
  3. Eligibility criteria expanded, about 7 wordsv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of May 2020 to Apr 27, 2020
    • Site details revised at 8 of 8 sites
    v4
  5. Start date: Apr 2020 to May 2020v3
  6. Start date: Mar 2020 to Apr 2020v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
244 patients, who have an emergency midline laparotomy for any gastrointestinal reason, will be randomized in a 1:1 ratio either to mesh group with a retrorectus prophylactic self-gripping mesh or to control group with 4:1 small stitch closure by continuous monofilament suture. They will be followed up at 30 days, 2 and 5 years to detect the incidence of incisional hernia.
Trial Details
NCT Number NCT04311788
Lead Sponsor University of Oulu
Collaborators: Helsinki University Central Hospital
Conditions
(from sponsor)		 Incisional Hernia, Emergency Laparotomy, Midline Laparotomy, Hernia Prevention
Related terms Incisional Hernia
Enrollment 109 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov