Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA)

• Verfasst von: Dop, Matthijs van den [VerfasserIn]
• Verfasst von: Sneiders, Dimitri [VerfasserIn]
• Verfasst von: Yurtkap, Yagmur [VerfasserIn]
• Verfasst von: Werba, Alexander [VerfasserIn]
• Verfasst von: van Klaveren, David [VerfasserIn]
• Verfasst von: Pierik, Robert E. G. J. M. [VerfasserIn]
• Verfasst von: Reim, Daniel [VerfasserIn]
• Verfasst von: Timmermans, Lucas [VerfasserIn]
• Verfasst von: Fortelny, René H. [VerfasserIn]
• Verfasst von: Mihaljevic, André L. [VerfasserIn]
• Verfasst von: Kleinrensink, Gert-Jan [VerfasserIn]
• Verfasst von: Tanis, Pieter J. [VerfasserIn]
• Verfasst von: Lange, Johan F. [VerfasserIn]
• Verfasst von: Jeekel, Johannes [VerfasserIn]
• Titel: Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA)
• Titelzusatz: long-term outcomes of a multicentre, double-blind, randomised controlled trial
• Verf.angabe: Louis Matthijs Van den Dop, Dimitri Sneiders, Yagmur Yurtkap, Alexander Werba, David van Klaveren, Robert E.G.J.M. Pierik, Daniel Reim, Lucas Timmermans, René H. Fortelny, André L. Mihaljevic, Gert-Jan Kleinrensink, Pieter J. Tanis, Johan F. Lange, and Johannes Jeekel, for the PRIMA Trialist Group
• E-Jahr: 2024
• Jahr: January 2024
• Umfang: 8 S.
• Illustrationen: Illustrationen
• Fussnoten: Online verfügbar: 22. November 2023, Artikelversion: 2. Januar 2024 ; Gesehen am 21.06.2024
• Titel Quelle: Enthalten in: The lancet. Regional health
• Ausgabe Quelle: Europe
• Ort Quelle: [Amsterdam] : Elsevier, 2021
• Jahr Quelle: 2024
• Band/Heft Quelle: 36(2024) vom: Jan., Artikel-ID 100787, Seite 1-8
• ISSN Quelle: 2666-7762
• DOI: doi:10.1016/j.lanepe.2023.100787
• Datenträger: Online-Ressource
• Sprache: eng
• Sach-SW: Incisional hernia
• Sach-SW: Onlay
• Sach-SW: Primary suture
• Sach-SW: Prophylactic mesh
• Sach-SW: Sublay
• K10plus-PPN: 189199798X

Abstract

Background - Incisional hernia occurs approximately in 40% of high-risk patients after midline laparotomy. Prophylactic mesh placement has shown promising results, but long-term outcomes are needed. The present study aimed to assess the long-term incisional hernia rates of the previously conducted PRIMA trial with radiological follow-up. - Methods - In the PRIMA trial, patients with increased risk of incisional hernia formation (AAA or BMI ≥27 kg/m2) were randomised in a 1:2:2 ratio to primary suture, onlay mesh or sublay mesh closure in three different countries in eleven institutions. Incisional hernia during follow-up was diagnosed by any of: CT, ultrasound and physical examination, or during surgery. Assessors and patients were blinded until 2-year follow-up. Time-to-event analysis according to intention-to-treat principle was performed with the Kaplan-Meier method and Cox proportional hazard models. Trial registration: NCT00761475 (ClinicalTrials.gov). - Findings - Between 2009 and 2012, 480 patients were randomized: 107 primary suture, 188 onlay mesh and 185 sublay mesh. Five-year incisional hernia rates were 53.4% (95% CI: 40.4-64.8), 24.7% (95% CI: 12.7-38.8), 29.8% (95% CI: 17.9-42.6), respectively. Compared to primary suture, onlay mesh (HR: 0.390, 95% CI: 0.248-0.614, p < 0.001) and sublay mesh (HR: 0.485, 95% CI: 0.309-0.761, p = 0.002) were associated with a significantly lower risk of incisional hernia development. - Interpretation - Prophylactic mesh placement remained effective in reducing incisional hernia occurrence after midline laparotomy in high-risk patients during long-term follow-up. Hernia rates in the primary suture group were higher than previously anticipated. - Funding - B. Braun.