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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Prophylactic Biosynthetic Mesh Placement
  A biosynthetic mesh (poly-4-hydroxybutyrate mesh) is placed prophylactically to reinforce abdominal wall closure during laparotomy closure.
• Процедура Direct suture
  Direct fascial suture closure of the abdominal wall after laparotomy without prophylactic mesh reinforcement.

Первичные конечные точки

• Incidence of incisional hernia at 12 months after laparotomy [Срок оценки: 12 months after laparotomy]

Вторичные конечные точки (5)

• Postoperative complications [Срок оценки: Within 30 days after surgery]
• Incidence of surgical site infection [Срок оценки: Within 30 days after surgery]
• Incidence of surgical site occurrences after emergency laparotomy [Срок оценки: Within 30 days after surgery]
• Incidence of surgical site occurrences requiring procedural intervention (SSOPI) [Срок оценки: Within 30 days after surgery]
• Incidence of incisional hernia at 2 and 3 years after surgery [Срок оценки: At 2 and 3 years after surgery]

Критерии участия

Критерии включения

All adult patients (≥18 years) undergoing emergency midline laparotomy will be eligible for inclusion, without upper age limit, to reflect real-world clinical practice.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Италия · 1 центр

• Policlinico di Roma Tor Vergata — Roma

Публикации

• 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 PMID 37727928
• 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. PMID 31672681
• 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. PMID 32953367
• 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. PMID 28444543
• 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 PMID 36026550
• 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.0b013e3182 PMID 23629524
• 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. PMID 26969665
• 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. PMID 32773624

Идентификаторы

NCT: NCT07753551 · 58.26 CET2 PUD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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