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
Matthijs L. Van den Dop, Dimitri Sneiders, Yağmur Yurtkap, Alexander Werba, David van Klaveren, Robert Pierik, Daniel Reim, Lucas Timmermans, René H. Fortelny, André L. Mihaljević, Gert‐Jan Kleinrensink, Pieter J. Tanis, Johan F. Lange, Johannes Jeekel, R. Grotelüschen, Rudie Roumen, Laurens van Baardewijk, Jerome van Brussel, M. van den Berg, Martijn F. Boomsma, Roy S. Dwarkasing, M. van der Wal, S.E. Buijk, An P. Jairam, Pim C.W. Burger, Hence J.M. Verhagen, D. de Jong, Pieter J. Klitsie, Lenny Lases, Arie van der Ham, Joris J. Harlaar, J. A. Charbon, B.J. Leenders, I. Dawson, Christof Seiler, Markus W. Büchler, Markus K. Diener, Christoph Schuhmacher, Jakob R. Izbicki, Asad Kutup, Peter Neuhaus, Panagiotis Fikatas, M. Golling, Dirk Laux, Christopher May, J. Nieuwenhuizen, Hasan H. Eker
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: ) 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.