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Randomized Controlled Trial Multicenter Study
Prophylactic Mesh Placement During Formation of an End-colostomy Long Term Rct on Effectiveness And Safety.
- Henk-Thijs Brandsma, Birgitta Me Hansson, Theo J Aufenacker, Nienke de Jong, Klaas Ca V Engelenburg, Chander Mahabier, Rogier Donders, Pascal Steenvoorde, Tammo S de Vries Reilingh, Hendrik Leendert van Westreenen, Marinus J Wiezer, de WiltJohannes H WJHWDepartment of Surgery, Radboud University Medical Centre, Nijmegen, The Netherlands., Maroeska Rovers, Camiel Rosman, and Dutch Prevent Study Group.
- Department of Surgery, Heelkunde Friesland Group, The Netherlands.
- Ann. Surg. 2023 Sep 1; 278 (3): e440e446e440-e446.
ObjectiveThe aim of this study was to determine if prophylactic mesh placement is an effective, safe, and cost-effective procedure to prevent parastomal hernia (PSH) formation in the long term.BackgroundA PSH is the most frequent complication after stoma formation. Prophylactic placement of a mesh has been suggested to prevent PSH, but long-term evidence to support this approach is scarce.MethodsIn this multicentre superiority trial patients undergoing the formation of a permanent colostomy were randomly assigned to either retromuscular polypropylene mesh reinforcement or conventional colostomy formation. Primary endpoint was the incidence of a PSH after 5 years. Secondary endpoints were morbidity, mortality, quality of life, and cost-effectiveness.ResultsA total of 150 patients were randomly assigned to the mesh group (n = 72) or nonmesh group (n = 78). For the long-term follow-up, 113 patients were analyzed, and 37 patients were lost to follow-up. After a median follow-up of 60 months (interquartile range: 48.6-64.4), 49 patients developed a PSH, 20 (27.8%) in the mesh group and 29 (37.2%) in the nonmesh group ( P = 0.22; RD: -9.4%; 95% CI: -24, 5.5). The cost related to the meshing strategy was € 2.239 lower than the nonmesh strategy (95% CI: 491.18, 3985.49), and quality-adjusted life years did not differ significantly between groups ( P = 0.959; 95% CI: -0.066, 0.070).ConclusionsProphylactic mesh placement during the formation of an end-colostomy is a safe procedure but does not reduce the incidence of PSH after 5 years of follow-up. It does, however, delay the onset of PSH without a significant difference in morbidity, mortality, or quality of life, and seems to be cost-effective.Copyright © 2023 Wolters Kluwer Health, Inc. All rights reserved.
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