Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA): long-term outcomes of a multicentre, double-blind, randomised controlled trial

Van den Dop, Louis; Sneiders, Dimitri; Yurtkap, Yagmur; Werba, Alexander; van Klaveren, David; Pierik, Robert; Reim, Daniel; Timmermans, Lucas; Fortelny, René; Mihaljevic, André; Kleinrensink, Gert-Jan; Tanis, Pieter; Lange, Johan; Jeekel, Johannes; Grotelüschen, Rainier; Roumen, Rudie; van Baardewijk, Laurens; van Brussel, Jerome; van den Berg, Michiel; Boomsma, Martijn; Dwarkasing, Roy; van der Wal, Maarten; Buijk, Steven; Jairam, An; Burger, Pim; Verhagen, Hence; De Jong, D.; Klitsie, Pieter; Lases, Lenny; van der Ham, Arie; Harlaar, Joris; Charbon, Jan; Leenders, Bart; Dawson, Imro; Seiler, Christof; Buchler, Markus; Diener, Markus; Schuhmacher, Christoph; Izbicki, Jakob; Kutup, Asad; Neuhaus, Peter; Fikatas, Panagiotis; Golling, Markus; Laux, Dirk; May, Christopher; Nieuwenhuizen, Jeroen; EKER, Hasan

doi:10.1016/j.lanepe.2023.100787

Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA): long-term outcomes of a multicentre, double-blind, randomised controlled trial

Van den Dop L. M., Sneiders D., Yurtkap Y., Werba A., van Klaveren D., Pierik R. E., ...Daha Fazla

The Lancet Regional Health - Europe, cilt.36, 2024 (SCI-Expanded, SSCI, Scopus)

Yayın Türü: Makale / Tam Makale
Cilt numarası: 36
Basım Tarihi: 2024
Doi Numarası: 10.1016/j.lanepe.2023.100787
Dergi Adı: The Lancet Regional Health - Europe
Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Social Sciences Citation Index (SSCI), Scopus
Anahtar Kelimeler: Incisional hernia, Prophylactic mesh, Onlay, Sublay, Primary suture
Sağlık Bilimleri Üniversitesi Adresli: Evet

Özet

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.