Prophylactic use of biologic mesh in ileal conduit (pubmic): initial report of a randomized controlled trial

You have accessJournal of UrologyCME1 Apr 2023MP65-04 PROPHYLACTIC USE OF BIOLOGIC MESH IN ILEAL CONDUIT (PUBMIC): INITIAL REPORT OF A RANDOMIZED CONTROLLED TRIAL Hooman Djaladat, Alireza Ghoreifi, Tapas Tejura, Gus Miranda, Jie Cai, Ileana Aldana Sotelo, Inderbir Gill, Sumeet Bhanvadia, Anne Schuckman, Mihir Desai, Monish Aron, Siamak Daneshmand, and Vinay Duddalwar Hooman DjaladatHooman Djaladat More articles by this author , Alireza GhoreifiAlireza Ghoreifi More articles by this author , Tapas TejuraTapas Tejura More articles by this author , Gus MirandaGus Miranda More articles by this author , Jie CaiJie Cai More articles by this author , Ileana Aldana SoteloIleana Aldana Sotelo More articles by this author , Inderbir GillInderbir Gill More articles by this author , Sumeet BhanvadiaSumeet Bhanvadia More articles by this author , Anne SchuckmanAnne Schuckman More articles by this author , Mihir DesaiMihir Desai More articles by this author , Monish AronMonish Aron More articles by this author , Siamak DaneshmandSiamak Daneshmand More articles by this author , and Vinay DuddalwarVinay Duddalwar More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003323.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Parastomal hernia (PSH) is a common complication following ileal conduit urinary diversion. The aim of this study is assess the effect of prophylactic biologic mesh on the PSH development in patients undergoing cystectomy and ileal conduit. METHODS: This phase III randomized controlled trial (#NCT02439060) included patients undergoing cystectomy and ileal conduit at USC between 2016 and 2021. Patients were randomized 1:1 to receive prophylactic biologic mesh (FlexHD, thickness 2.5 mm) using sublay intraperitoneal technique. Follow-ups included physical exam and CT imaging every 4-6 months up to 2 years. The primary and secondary endpoints were radiological (Moreno classification) and clinical PSH, respectively. RESULTS: A total of 146 patients were enrolled and randomized to mesh (n=72) and control (n=74). Two arms were similar in terms of clinical features (Table 1). All surgeries and mesh placements were accomplished without intraoperative complication. Median operative time was 31 minutes longer in patients receiving mesh. Postoperative wound/stoma and infectious complications were similar between the mesh and control groups (7% vs. 8%, and 26% vs. 22%, respectively). Within a median follow-up of 13 months, the incidence of radiological and clinical PSH was 26% (26% in each arm) and 11% (10% in mesh vs. 12% controls), with median time to radiological and clinical PSH of 8.5 and 15.6 months, respectively. No definite mesh-related adverse events were reported. On multivariable Cox regression analysis, prior radiation (HR 3.6, p=0.02) and pathological T stage>2 (HR 2, p=0.06) had significant and borderline association with an increased risk of PSH, respectively. PSH-free survivals in the mesh and control groups were 77% vs. 76% at 1-year, 72% vs. 62% at 2-year, and 58% vs. 44% at 3-year, respectively (Figure 1). CONCLUSIONS: These initial results suggest that implementation of biologic mesh at the time of ileal conduit construction is safe without significant protective effect in first year, yet may decrease PSH development afterward. Source of Funding: Musculoskeletal Transplant Foundation © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e891 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hooman Djaladat More articles by this author Alireza Ghoreifi More articles by this author Tapas Tejura More articles by this author Gus Miranda More articles by this author Jie Cai More articles by this author Ileana Aldana Sotelo More articles by this author Inderbir Gill More articles by this author Sumeet Bhanvadia More articles by this author Anne Schuckman More articles by this author Mihir Desai More articles by this author Monish Aron More articles by this author Siamak Daneshmand More articles by this author Vinay Duddalwar More articles by this author Expand All Advertisement PDF downloadLoading ...