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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Rome Tor Vergata

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

189 Participants
are divided into 2 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