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Prophylactic Mesh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT)
Sponsor: University of Rome Tor Vergata
Summary
The PREEMPT trial is a multicenter randomized controlled trial comparing prophylactic onlay biosynthetic mesh reinforcement with primary suture closure in adult patients undergoing emergency midline laparotomy. Participants will be randomized in a 1:1 ratio. The primary endpoint is the incidence of incisional hernia at 1 year. Secondary endpoints include postoperative complications, surgical site occurrences, pain, operative time, hospital stay, morbidity, mortality, quality of life, and long-term hernia incidence.
Official title: PRophylactic mEsh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT): A Multicenter Randomized Clinical Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
189
Start Date
2026-09-01
Completion Date
2031-08-31
Last Updated
2026-08-07
Healthy Volunteers
No
Interventions
Prophylactic Biosynthetic Mesh Placement
A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.
Direct suture
Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.
Locations (1)
Policlinico di Roma Tor Vergata
Roma, Italy