Clinical Trial

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

Active, Not Recruiting
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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.
Summary
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.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2020-03-15; most recent amendment 2024-01-31.
Status change: Recruiting → Active, Not Recruiting 2023-02-03
Status change: Not Yet Recruiting → Recruiting 2020-04-27
Trial Details
NCT Number NCT04311788
Lead Sponsor University of Oulu
Collaborators: Helsinki University Central Hospital
Conditions Incisional Hernia, Emergency Laparotomy, Midline Laparotomy, Hernia Prevention
Enrollment 109 participants
Start Date 2020-04-27
Primary Completion 2025-02-03 (estimated)
Study Completion 2028-03 (estimated)
Updated on ClinicalTrials.gov 2024-02-01