Prophylactic Mesh Reinforcement Versus Primary Closure After Emergency Midline Laparotomy (PREEMPT) (PREEMPT)
5 sierpnia 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
189
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Andrea Martina Guida, MD
- Numer telefonu: +390620908126
- E-mail: andreamartina.guida@ptvonline.it
Kopia zapasowa kontaktu do badania
- Nazwa: Andrea Divizia, MD, PhD
- E-mail: andrea.divizia@ptvonline.it
Lokalizacje studiów
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Roma, Włochy
- Policlinico di Roma Tor Vergata
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Nie
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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.
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A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.
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Aktywny 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.
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Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Incidence of incisional hernia at 12 months after laparotomy
Ramy czasowe: 12 months after laparotomy
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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.
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12 months after laparotomy
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Postoperative complications
Ramy czasowe: Within 30 days after surgery
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Postoperative complications will be assessed according to the Clavien-Dindo classification.
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Within 30 days after surgery
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Incidence of surgical site infection
Ramy czasowe: Within 30 days after surgery
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The incidence of surgical site infection (superficial, deep, and organ-space infection) occurring after laparotomy will be evaluated and compared between treatment groups
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Within 30 days after surgery
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Incidence of surgical site occurrences after emergency laparotomy
Ramy czasowe: Within 30 days after surgery
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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.
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Within 30 days after surgery
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Incidence of surgical site occurrences requiring procedural intervention (SSOPI)
Ramy czasowe: Within 30 days after surgery
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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.
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Within 30 days after surgery
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Incidence of incisional hernia at 2 and 3 years after surgery
Ramy czasowe: At 2 and 3 years after surgery
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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.
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At 2 and 3 years after surgery
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Operative time
Ramy czasowe: Intraoperatively
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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.
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Intraoperatively
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Readmission and reoperation rates
Ramy czasowe: Within 30 days after surgery
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The rates of unplanned hospital readmission and reoperation after the index surgery will be assessed and compared between treatment groups.
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Within 30 days after surgery
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30-day postoperative morbidity and mortality
Ramy czasowe: Within 30 days after surgery
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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.
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Within 30 days after surgery
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Postoperative pain assessed by Visual Analogue Scale (VAS)
Ramy czasowe: Postoperative days 1, 3, and 5
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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.
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Postoperative days 1, 3, and 5
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Length of hospital stay
Ramy czasowe: Through hospital discharge, up to 30 days after surgery
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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.
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Through hospital discharge, up to 30 days after surgery
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Quality of life assessed by the Short Form-36 (SF-36) questionnaire
Ramy czasowe: At 12 months after surgery
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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.
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At 12 months after surgery
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Andrea Divizia, MD, PhD, UOSD Chirurgia d'Urgenza, Policlinico di Roma Tor Vergata
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Lima HVG, Rasslan R, Novo FCF, Lima TMA, Damous SHB, Bernini CO, Montero EFS, Utiyama EM. Prevention of Fascial Dehiscence with Onlay Prophylactic Mesh in Emergency Laparotomy: A Randomized Clinical Trial. J Am Coll Surg. 2020 Jan;230(1):76-87. doi: 10.1016/j.jamcollsurg.2019.09.010. Epub 2019 Oct 28.
- Deerenberg EB, Henriksen NA, Antoniou GA, Antoniou SA, Bramer WM, Fischer JP, Fortelny RH, Gok H, Harris HW, Hope W, Horne CM, Jensen TK, Kockerling F, Kretschmer A, Lopez-Cano M, Malcher F, Shao JM, Slieker JC, de Smet GHJ, Stabilini C, Torkington J, Muysoms FE. Updated guideline for closure of abdominal wall incisions from the European and American Hernia Societies. Br J Surg. 2022 Nov 22;109(12):1239-1250. doi: 10.1093/bjs/znac302.
- Sanders DL, Pawlak MM, Simons MP, Aufenacker T, Balla A, Berger C, Berrevoet F, de Beaux AC, East B, Henriksen NA, Klugar M, Langaufova A, Miserez M, Morales-Conde S, Montgomery A, Pettersson PK, Reinpold W, Renard Y, Slezakova S, Whitehead-Clarke T, Stabilini C. Midline incisional hernia guidelines: the European Hernia Society. Br J Surg. 2023 Nov 9;110(12):1732-1768. doi: 10.1093/bjs/znad284. No abstract available.
- Ahmed J, Hasnain N, Fatima I, Malik F, Chaudhary MA, Ahmad J, Malik M, Malik L, Osama M, Baig MZ, Khosa F, Bhora F. Prophylactic Mesh Placement for the Prevention of Incisional Hernia in High-Risk Patients After Abdominal Surgery: A Systematic Review and Meta-Analysis. Cureus. 2020 Sep 16;12(9):e10491. doi: 10.7759/cureus.10491.
- Rampado S, Geron A, Pirozzolo G, Ganss A, Pizzolato E, Bardini R. Cost analysis of incisional hernia repair with synthetic mesh and biological mesh: an Italian study. Updates Surg. 2017 Sep;69(3):375-381. doi: 10.1007/s13304-017-0453-9. Epub 2017 Apr 25.
- Rogmark P, Petersson U, Bringman S, Eklund A, Ezra E, Sevonius D, Smedberg S, Osterberg J, Montgomery A. Short-term outcomes for open and laparoscopic midline incisional hernia repair: a randomized multicenter controlled trial: the ProLOVE (prospective randomized trial on open versus laparoscopic operation of ventral eventrations) trial. Ann Surg. 2013 Jul;258(1):37-45. doi: 10.1097/SLA.0b013e31828fe1b2.
- Langbach O, Bukholm I, Benth JS, Rokke O. Long-term quality of life and functionality after ventral hernia mesh repair. Surg Endosc. 2016 Nov;30(11):5023-5033. doi: 10.1007/s00464-016-4850-9. Epub 2016 Mar 11.
- Dadashzadeh ER, Huckaby LV, Handzel R, Hossain MS, Sanin GD, Anto VP, Bou-Samra P, Moses JB, Cai S, Phelos HM, Simmons RL, Rosengart MR, van der Windt DJ. The Risk of Incarceration During Nonoperative Management of Incisional Hernias: A Population-based Analysis of 30,998 Patients. Ann Surg. 2022 Feb 1;275(2):e488-e495. doi: 10.1097/SLA.0000000000003916.
- Argudo N, Pereira JA, Sancho JJ, Membrilla E, Pons MJ, Grande L. Prophylactic synthetic mesh can be safely used to close emergency laparotomies, even in peritonitis. Surgery. 2014 Nov;156(5):1238-44. doi: 10.1016/j.surg.2014.04.035. Epub 2014 Jul 10.
- Depuydt M, Allaeys M, de Carvalho LA, Vanlander A, Berrevoet F. Prophylactic Mesh After Midline Laparotomy: Evidence is out There, but why do Surgeons Hesitate? World J Surg. 2021 May;45(5):1349-1361. doi: 10.1007/s00268-020-05898-0. Epub 2021 Feb 8.
- Jairam AP, Lopez-Cano M, Garcia-Alamino JM, Pereira JA, Timmermans L, Jeekel J, Lange J, Muysoms F. Prevention of incisional hernia after midline laparotomy with prophylactic mesh reinforcement: a meta-analysis and trial sequential analysis. BJS Open. 2020 Jun;4(3):357-368. doi: 10.1002/bjs5.50261. Epub 2020 Feb 14.
- Korenkov M, Paul A, Sauerland S, Neugebauer E, Arndt M, Chevrel JP, Corcione F, Fingerhut A, Flament JB, Kux M, Matzinger A, Myrvold HE, Rath AM, Simmermacher RK. Classification and surgical treatment of incisional hernia. Results of an experts' meeting. Langenbecks Arch Surg. 2001 Feb;386(1):65-73. doi: 10.1007/s004230000182.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
1 września 2026
Zakończenie podstawowe (Szacowany)
31 sierpnia 2029
Ukończenie studiów (Szacowany)
31 sierpnia 2031
Daty rejestracji na studia
Pierwszy przesłany
29 lipca 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
5 sierpnia 2026
Pierwszy wysłany (Rzeczywisty)
7 sierpnia 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
7 sierpnia 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
5 sierpnia 2026
Ostatnia weryfikacja
1 lipca 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 58.26 CET2 PUD
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
produkt wyprodukowany i wyeksportowany z USA
Nie
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