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

5 août 2026 mis à jour par: Andrea Divizia, University of Rome Tor Vergata

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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

189

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Italie
      • Roma, Italie
        • Policlinico di Roma Tor Vergata

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Mesh-repair group
Patients randomized to this arm will receive prophylactic onlay placement of a biosynthetic mesh (poly-4-hydroxybutyrate mesh) to reinforce the abdominal wall closure at the time of laparotomy closure, in addition to standard surgical closure. A minimum overlap of 3 cm on all sides of the incision will be ensured. Mesh fixation will be achieved with four sutures placed at the cardinal points only.
Dispositif: Prophylactic Biosynthetic Mesh Placement
A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.
Comparateur actif: Direct suture group
Patients randomized to this arm will receive standard abdominal wall closure according to European Hernia Society (EHS) guidelines: a slowly absorbable running suture will be used in all centers, employing a continuous small-bites technique. Tissue bites of 5-9 mm from the wound edges will incorporate the aponeurosis only, with stitches placed 5 mm apart to ensure uniform tension distribution, aiming for a suture length to wound length ratio of at least 4:1.
Procédure: Direct suture
Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Incidence of incisional hernia at 12 months after laparotomy
Délai: 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.
12 months after laparotomy

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Postoperative complications
Délai: Within 30 days after surgery
Postoperative complications will be assessed according to the Clavien-Dindo classification.
Within 30 days after surgery
Incidence of surgical site infection
Délai: 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
Within 30 days after surgery
Incidence of surgical site occurrences after emergency laparotomy
Délai: 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.
Within 30 days after surgery
Incidence of surgical site occurrences requiring procedural intervention (SSOPI)
Délai: 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.
Within 30 days after surgery
Incidence of incisional hernia at 2 and 3 years after surgery
Délai: 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.
At 2 and 3 years after surgery

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Operative time
Délai: 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.
Intraoperatively
Readmission and reoperation rates
Délai: 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.
Within 30 days after surgery
30-day postoperative morbidity and mortality
Délai: 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.
Within 30 days after surgery
Postoperative pain assessed by Visual Analogue Scale (VAS)
Délai: 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.
Postoperative days 1, 3, and 5
Length of hospital stay
Délai: 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.
Through hospital discharge, up to 30 days after surgery
Quality of life assessed by the Short Form-36 (SF-36) questionnaire
Délai: 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.
At 12 months after surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Rome Tor Vergata

Collaborateurs

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

Les enquêteurs

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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 septembre 2026

Achèvement primaire (Estimé)

31 août 2029

Achèvement de l'étude (Estimé)

31 août 2031

Dates d'inscription aux études

Première soumission

29 juillet 2026

Première soumission répondant aux critères de contrôle qualité

5 août 2026

Première publication (Réel)

7 août 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

7 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

5 août 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 58.26 CET2 PUD

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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