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

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.

Conditions

• Incisional Hernia After Midline Laparotomy
• Emergency Abdominal Surgery

Interventions

DEVICE

Prophylactic Biosynthetic Mesh Placement

A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.

PROCEDURE

Direct suture

Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

  collaborator OTHER

• San Filippo Neri General Hospital

  collaborator OTHER

• San Giovanni Addolorata Hospital

  collaborator OTHER

• Santa Maria della Pieta Hospital - Nola

  collaborator OTHER

• Buccheri La Ferla Hospital, Palermo

  collaborator OTHER

• Cardarelli Hospital, Naples, Italy

  collaborator UNKNOWN

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  collaborator OTHER

• University of Rome Tor Vergata

  lead OTHER

Principal Investigators

• Andrea Divizia, MD, PhD · UOSD Chirurgia d'Urgenza, Policlinico di Roma Tor Vergata

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2029-08-31

Completion

2031-08-31

Countries

• Italy

Study Locations