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

5 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

189

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Italia
      • Roma, Italia
        • Policlinico di Roma Tor Vergata

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: Prophylactic Biosynthetic Mesh Placement
A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.
Comparatore attivo: 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.
Procedura: Direct suture
Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of incisional hernia at 12 months after laparotomy
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Postoperative complications
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Operative time
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Rome Tor Vergata

Collaboratori

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

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

31 agosto 2029

Completamento dello studio (Stimato)

31 agosto 2031

Date di iscrizione allo studio

Primo inviato

29 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 agosto 2026

Primo Inserito (Effettivo)

7 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 agosto 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 58.26 CET2 PUD

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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