TY - JOUR
T1 - Prevention of incisional hernia with prophylactic onlay and sublay mesh reinforcement vs. primary suture only in midline laparotomies (PRIMA)
T2 - long-term outcomes of a multicentre, double-blind, randomised controlled trial
AU - Van den Dop, Louis Matthijs
AU - Sneiders, Dimitri
AU - Yurtkap, Yagmur
AU - PRIMA Trialist Group
AU - Werba, Alexander
AU - van Klaveren, David
AU - Pierik, Robert E.G.J.M.
AU - Reim, Daniel
AU - Timmermans, Lucas
AU - Fortelny, René H.
AU - Mihaljevic, André L.
AU - Kleinrensink, Gert Jan
AU - Tanis, Pieter J.
AU - Lange, Johan F.
AU - Jeekel, Johannes
AU - Grotelüschen, Rainier
AU - Roumen, Rudie
AU - van Baardewijk, Laurens
AU - van Brussel, Jerome
AU - van den Berg, Michiel
AU - Boomsma, Martijn
AU - Dwarkasing, Roy
AU - van der Wal, Maarten
AU - Buijk, Steven
AU - Jairam, An
AU - Burger, Pim C.W.
AU - Verhagen, Hence
AU - De Jong, D.
AU - Klitsie, Pieter
AU - Lases, Lenny
AU - van der Ham, Arie
AU - Harlaar, Joris
AU - Charbon, Jan
AU - Leenders, Bart
AU - Dawson, Imro
AU - Seiler, Christof
AU - Buchler, Markus
AU - Diener, Markus
AU - Schuhmacher, Christoph
AU - Izbicki, Jakob
AU - Kutup, Asad
AU - Neuhaus, Peter
AU - Fikatas, Panagiotis
AU - Golling, Markus
AU - Laux, Dirk
AU - May, Christopher
AU - Nieuwenhuizen, Jeroen
AU - Eker, Hasan H.
N1 - Publisher Copyright: © 2023 The Author(s)
PY - 2024/1
Y1 - 2024/1
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85177816218&partnerID=8YFLogxK
U2 - 10.1016/j.lanepe.2023.100787
DO - 10.1016/j.lanepe.2023.100787
M3 - Article
C2 - 38188275
AN - SCOPUS:85177816218
SN - 2666-7762
VL - 36
JO - The Lancet Regional Health - Europe
JF - The Lancet Regional Health - Europe
M1 - 100787
ER -