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Prophylactic Mesh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT)

Study acronym: PREEMPT
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07753551
Lead Sponsor University of Rome Tor Vergata
Collaborators: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, San Filippo Neri General Hospital, San Giovanni Addolorata Hospital, Santa Maria della Pieta Hospital - Nola, Buccheri La Ferla Hospital, Palermo, Cardarelli Hospital, Naples, Italy, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions
(from sponsor)		 Incisional Hernia After Midline Laparotomy, Emergency Abdominal Surgery
Related terms Emergencies, Incisional Hernia
Enrollment 189 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov