Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

5 augustus 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

189

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Italië
      • Roma, Italië
        • Policlinico di Roma Tor Vergata

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Apparaat: Prophylactic Biosynthetic Mesh Placement
A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.
Actieve vergelijker: 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.
Procedure: Direct suture
Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Incidence of incisional hernia at 12 months after laparotomy
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative complications
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Operative time
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Rome Tor Vergata

Medewerkers

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

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

31 augustus 2029

Studie voltooiing (Geschat)

31 augustus 2031

Studieregistratiedata

Eerst ingediend

29 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 augustus 2026

Eerst geplaatst (Werkelijk)

7 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

5 augustus 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 58.26 CET2 PUD

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren