Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair

Официальное название

Prophylactic Mesh Reinforcement After Open Aortic Aneurysm Repair: a Retrospective Study

Обзор

The goal of this retrospective observational study is to evaluate whether prophylactic mesh reinforcement during abdominal wall closure can prevent incisional hernias (IH) in patients undergoing open abdominal aortic aneurysm (AAA) repair. The main questions it aims to answer are: * Does mesh reinforcement reduce the incidence of incisional hernias? * What is the frequency of associated postoperative complications? Researchers will compare the outcomes of patients who underwent mesh-reinforced closures to literature-reported outcomes for non-mesh cases to assess differences in IH incidence and complications. Participants will: * Undergo clinical follow-ups and abdominal ultrasounds to detect IH. * Complete quality-of-life questionnaires (EQ-5D and PROMIS).

Вмешательства

• Процедура Prophylactic retromuscular mesh reinforcement
  Prophylactic retromuscular mesh placement involves reinforcing the abdominal wall during closure after open abdominal aortic aneurysm (AAA) repair to prevent incisional hernias. This technique creates a retro-muscular space by carefully dissecting the rectus abdominis muscles from the posterior rectus sheath. A self-gripping polyester mesh or composite mesh is placed in this space, extending 4 cm beyond the midline on each side, ensuring tension-free coverage. The mesh is secured at key points,

Первичные конечные точки

• Rate of incisional hernias [Срок оценки: january-april 2025]

Вторичные конечные точки (5)

• Rate of fascial dehiscence [Срок оценки: january-april 2025]
• Rate of seromas [Срок оценки: january-april 2025]
• Rate of surgical site infection [Срок оценки: january-april 2025]
• Rate of hematomas [Срок оценки: january-april 2025]
• Operative time [Срок оценки: january-april 2025]

Критерии участия

Критерии включения

• Adult patients (≥18 years old) who underwent open abdominal aortic aneurysm (AAA) repair with prophylactic retromuscular mesh reinforcement between January 2019 and January 2024
• Availability of complete medical records, including preoperative history, surgical details, and postoperative follow-up data
• Attendance at a clinical follow-up examination at least one year after the procedure
• General informed consent signed for the use of medical data for research purposes

Критерии исключения

• Patients with incomplete or missing medical records, including preoperative, intraoperative, or follow-up data
• Patients who required a re-laparotomy involving incision or suture of the prophylactic mesh and subsequently developed an incisional hernia.
• Patients who did not attend the required clinical follow-up examination at least one year postoperatively.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Швейцария · 1 центр

• HFR Hopitaux Fribourgeois — Villars-sur-Glâne

Публикации

• Endo T, Miyahara K, Shirasu T, Mochizuki Y, Taniguchi R, Takayama T, Hoshina K. Risk Factors for Incisional Hernia After Open Abdominal Aortic Aneurysm Repair. In Vivo. 2023 Nov-Dec;37(6):2803-2807. doi: 10.21873/invivo.13393. PMID 37905664
• Antoniou GA, Muysoms FE, Deerenberg EB. Updated Guideline on Abdominal Wall Closure from the European and American Hernia Societies: Transferring Recommendations to Clinical Practice for Vascular Surgeons. Eur J Vasc Endovasc Surg. 2023 Jun;65(6):774-777. doi: 10.1016/j.ejvs.2023.02.009. Epub 2023 Feb 16. No abstract available. PMID 36804613
• Antoniou GA, Georgiadis GS, Antoniou SA, Granderath FA, Giannoukas AD, Lazarides MK. Abdominal aortic aneurysm and abdominal wall hernia as manifestations of a connective tissue disorder. J Vasc Surg. 2011 Oct;54(4):1175-81. doi: 10.1016/j.jvs.2011.02.065. Epub 2011 Aug 6. PMID 21820838
• DeAngelo N, Perez AJ. Hernia Prevention: The Role of Technique and Prophylactic Mesh to Prevent Incisional Hernias. Surg Clin North Am. 2023 Oct;103(5):847-857. doi: 10.1016/j.suc.2023.04.021. Epub 2023 Jun 9. PMID 37709391
• Franchi M, Ghezzi F, Buttarelli M, Tateo S, Balestreri D, Bolis P. Incisional hernia in gynecologic oncology patients: a 10-year study. Obstet Gynecol. 2001 May;97(5 Pt 1):696-700. doi: 10.1016/s0029-7844(01)01192-9. PMID 11339918
• Sorensen LT, Hemmingsen UB, Kirkeby LT, Kallehave F, Jorgensen LN. Smoking is a risk factor for incisional hernia. Arch Surg. 2005 Feb;140(2):119-23. doi: 10.1001/archsurg.140.2.119. PMID 15723991
• Goodenough CJ, Ko TC, Kao LS, Nguyen MT, Holihan JL, Alawadi Z, Nguyen DH, Flores JR, Arita NT, Roth JS, Liang MK. Development and validation of a risk stratification score for ventral incisional hernia after abdominal surgery: hernia expectation rates in intra-abdominal surgery (the HERNIA Project). J Am Coll Surg. 2015 Apr;220(4):405-13. doi: 10.1016/j.jamcollsurg.2014.12.027. Epub 2015 Jan 2. PMID 25690673
• Montalti R, Mimmo A, Rompianesi G, Serra V, Cautero N, Ballarin R, De Ruvo N, Cunningham Gerring R, Enrico Gerunda G, Di Benedetto F. Early use of mammalian target of rapamycin inhibitors is an independent risk factor for incisional hernia development after liver transplantation. Liver Transpl. 2012 Feb;18(2):188-94. doi: 10.1002/lt.22445. PMID 21987434

Идентификаторы

NCT: NCT06762561 · 2348

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗