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

5. august 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

189

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Enhet: Prophylactic Biosynthetic Mesh Placement
A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.
Aktiv komparator: 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.
Fremgangsmåte: Direct suture
Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence of incisional hernia at 12 months after laparotomy
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Postoperative complications
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Operative time
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Rome Tor Vergata

Samarbeidspartnere

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

Etterforskere

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

Publikasjoner og nyttige lenker

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Studierekorddatoer

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Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

31. august 2029

Studiet fullført (Antatt)

31. august 2031

Datoer for studieregistrering

Først innsendt

29. juli 2026

Først innsendt som oppfylte QC-kriteriene

5. august 2026

Først lagt ut (Faktiske)

7. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

5. august 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 58.26 CET2 PUD

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