About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
Age < 18 years
Minimally invasive surgery (laparoscopic or robotic approaches)
Elective surgery
Surgery requiring an open abdomen and its closure
Trial design
Treatments tested in this trial
- Prophylactic Biosynthetic Mesh Placement
- Direct suture
Treatment groups
Sponsors and collaborators
University of Rome Tor Vergata
Lead sponsor
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
Collaborator
San Filippo Neri General Hospital
Collaborator
San Giovanni Addolorata Hospital
Collaborator
Santa Maria della Pieta Hospital - Nola
Collaborator
Buccheri La Ferla Hospital, Palermo
Collaborator
Cardarelli Hospital, Naples, Italy
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator