Emergency Abdominal Surgery, Incisional Hernia After Midline Laparotomy
Conditions
Keywords
incisional hernia, laparotomy, emergency, primary prevention, surgical mesh
Brief 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.
Detailed description
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.
Interventions
DEVICEProphylactic Biosynthetic Mesh Placement
A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.
PROCEDUREDirect suture
Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.
Sponsors
University of Rome Tor Vergata
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
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of incisional hernia at 12 months after laparotomy | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative complications | Within 30 days after surgery | Postoperative complications will be assessed according to the Clavien-Dindo classification. |
| Incidence of surgical site infection | 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 |
| Incidence of surgical site occurrences after emergency laparotomy | 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. |
| Incidence of surgical site occurrences requiring procedural intervention (SSOPI) | 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. |
| Incidence of incisional hernia at 2 and 3 years after surgery | 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. |
Countries
Italy
Contacts
CONTACTAndrea Martina Guida, MD
CONTACTAndrea Divizia, MD, PhD
PRINCIPAL_INVESTIGATORAndrea Divizia, MD, PhD
UOSD Chirurgia d'Urgenza, Policlinico di Roma Tor Vergata
Outcome results
None listed