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NCT Number: NCT07753551

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

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.

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Key information

Conditions

Incisional Hernia After Midline Laparotomy Disease Attributes Emergencies Emergency Abdominal Surgery Hernia Incisional Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico di Roma Tor Vergata

Roma, Italy

About this study

Incisional hernia (IH) is a frequent complication after midline laparotomy, with rates up to 50-70% in high-risk or emergency settings. Emergency procedures are particularly prone to IH due to contamination and suboptimal conditions. Prophylactic mesh reinforcement has been shown to significantly reduce IH rates in elective surgery without increasing wound morbidity, but evidence in emergency settings is scarce. Biosynthetic meshes, with favorable safety and cost profiles in contaminated fields, may offer an effective preventive strategy.

The PREEMPT trial is a multicenter, randomized (1:1) controlled study including adult patients undergoing emergency midline laparotomy. Eligible patients will be randomized to prophylactic onlay biosynthetic mesh reinforcement versus primary suture closure. The primary outcome is the incidence of incisional hernia at 1 year. Secondary outcomes include postoperative complications, surgical site occurrences, pain (VAS), operative time, length of hospital stay, 30-day morbidity and mortality, readmission and reoperation rates, and long-term quality of life (SF-36) and hernia incidence at 2 and 3 years.

The PREEMPT trial is a multicenter randomized clinical trial of patients undergoing emergency laparotomy. We aim to evaluate whether prophylactic bio-synthetic mesh reinforcement could reduce the incidence of incisional hernia in patients undergoing emergency midline laparotomy compared with primary suture closure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All adult patients (≥18 years) undergoing emergency midline laparotomy will be eligible for inclusion, without upper age limit, to reflect real-world clinical practice.

Exclusion criteria

  • Age < 18 years
  • Minimally invasive surgery (laparoscopic or robotic approaches)
  • Elective surgery
  • Surgery requiring an open abdomen and its closure
  • Fecal peritonitis
  • Previous midline laparotomy
  • Pregnancy or breastfeeding
  • Conditions that would impair the possibility of understanding and giving of informed consent.

Treatment and study plan

Prophylactic Biosynthetic Mesh Placement

Device

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

Direct Suture

Procedure

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

Primary outcomes

  1. Incidence of incisional hernia at 12 months after laparotomy

    Time frame: 12 months after laparotomy

    The primary outcome is the occurrence of incisional hernia within 12 months after laparotomy, assessed by clinical examination and/or imaging according to the study protocol. The incidence of incisional hernia will be compared between patients receiving prophylactic biosynthetic mesh reinforcement and patients undergoing standard abdominal wall closure without mesh.

Secondary outcomes

  1. Postoperative complications

    Time frame: Within 30 days after surgery

    Postoperative complications will be assessed according to the Clavien-Dindo classification.

  2. Incidence of surgical site infection

    Time frame: Within 30 days after surgery

    The incidence of surgical site infection (superficial, deep, and organ-space infection) occurring after laparotomy will be evaluated and compared between treatment groups

  3. Incidence of surgical site occurrences after emergency laparotomy

    Time frame: Within 30 days after surgery

    The incidence of surgical site occurrences (SSO), including surgical site infection, seroma, wound dehiscence, hematoma, and other wound-related complications, will be assessed and compared between treatment groups.

  4. Incidence of surgical site occurrences requiring procedural intervention (SSOPI)

    Time frame: Within 30 days after surgery

    The incidence of surgical site occurrences requiring procedural intervention (SSOPI) will be assessed. SSOPI include surgical site occurrences requiring invasive treatment, such as wound drainage, percutaneous intervention, surgical debridement, or other procedural management.

  5. Incidence of incisional hernia at 2 and 3 years after surgery

    Time frame: At 2 and 3 years after surgery

    The long-term incidence of incisional hernia will be assessed at 2 and 3 years after laparotomy and compared between patients receiving prophylactic biosynthetic mesh reinforcement and patients undergoing standard abdominal wall closure without mesh.

Other outcomes

  1. Operative time

    Time frame: Intraoperatively

    Operative time will be measured from skin incision to completion of skin closure and compared between patients undergoing prophylactic biosynthetic mesh reinforcement and patients undergoing standard abdominal wall closure.

  2. Readmission and reoperation rates

    Time frame: Within 30 days after surgery

    The rates of unplanned hospital readmission and reoperation after the index surgery will be assessed and compared between treatment groups.

  3. 30-day postoperative morbidity and mortality

    Time frame: Within 30 days after surgery

    Thirty-day postoperative morbidity and mortality will be assessed, including the occurrence of postoperative complications and death within 30 days after the index surgery. Postoperative complications will be recorded and compared between treatment groups.

  4. Postoperative pain assessed by Visual Analogue Scale (VAS)

    Time frame: Postoperative days 1, 3, and 5

    Postoperative pain will be assessed using the Visual Analog Scale (VAS), a 0-10 scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain scores will be compared between treatment groups.

  5. Length of hospital stay

    Time frame: Through hospital discharge, up to 30 days after surgery

    Length of hospital stay will be measured as the number of days from the date of the index surgery to hospital discharge and will be compared between treatment groups.

  6. Quality of life assessed by the Short Form-36 (SF-36) questionnaire

    Time frame: At 12 months after surgery

    Quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life. Scores will be compared between treatment groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Divizia, MD, PhD

CONTACT

[email protected]

Andrea Martina Guida, MD

CONTACT

[email protected]

+390620908126

Sponsors and collaborators

Lead sponsor

University of Rome Tor Vergata

Other

Collaborators

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
  • Buccheri La Ferla Hospital, Palermo
  • Cardarelli Hospital, Naples, Italy
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  • San Filippo Neri General Hospital
  • San Giovanni Addolorata Hospital
  • Santa Maria della Pieta Hospital - Nola

Registry information

Official study title

PRophylactic mEsh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT): A Multicenter Randomized Clinical Trial

Acronym: PREEMPT

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Aug 7, 2026
Registry last updated
Aug 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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