PD21-06 OUTCOMES OF PROPHYLACTIC USE OF BIOLOGIC MESH IN ILEAL CONDUIT (PUBMIC) TRIAL: EXTENDED FOLLOW-UP BEYOND TWO YEARS

You have accessJournal of UrologyReconstruction: Augmentation, Substitution, Diversion (PD21)1 May 2024PD21-06 OUTCOMES OF PROPHYLACTIC USE OF BIOLOGIC MESH IN ILEAL CONDUIT (PUBMIC) TRIAL: EXTENDED FOLLOW-UP BEYOND TWO YEARS Hooman Djaladat, Alireza Ghoreifi, Farshad Sheybaee Moghaddam, Tapas Tejura, Gus Miranda, Rene Sotelo, Inderbir Gill, Sumeet Bhanvadia, Anne Schuckman, Mihir Desai, Monish Aron, Siamak Daneshmand, and Vinay Duddalwar Hooman DjaladatHooman Djaladat , Alireza GhoreifiAlireza Ghoreifi , Farshad Sheybaee MoghaddamFarshad Sheybaee Moghaddam , Tapas TejuraTapas Tejura , Gus MirandaGus Miranda , Rene SoteloRene Sotelo , Inderbir GillInderbir Gill , Sumeet BhanvadiaSumeet Bhanvadia , Anne SchuckmanAnne Schuckman , Mihir DesaiMihir Desai , Monish AronMonish Aron , Siamak DaneshmandSiamak Daneshmand , and Vinay DuddalwarVinay Duddalwar View All Author Informationhttps://doi.org/10.1097/01.JU.0001008888.07102.14.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: We have previously reported the initial results of the prophylactic use of biologic mesh in ileal conduit (PUBMIC) trial within two years. Herein, we report the outcomes of this trial with an extended follow-up. METHODS: In this phase III randomized trial, 146 patients who underwent cystectomy and ileal conduit between 2016 and 2021 were included. Patients were randomized 1:1 to undergo prophylactic peri-stomal biologic mesh vs. no mesh. Follow-ups included physical exam and computed tomography every 4-6 months until the study endpoints or death were reached. The primary outcome was radiological parastomal hernia (PSH), and secondary outcomes included clinical PSH and mesh-related complications. RESULTS: Two arms were similar in terms of demographics and clinical/surgical features. Within the first 2 years following surgery, 44 and 33 patients were censored due to death or PSH, respectively (42 mesh and 35 control cases). The other 69 patients were followed for a median duration of 30 (22-45) months. In total, 39 (26.7%) patients developed radiological PSH (26.4% in mesh vs. 27% controls), of which 6 occurred after 2 years (3 in each arm). Incidence of clinical PSH was 11.6% (11.1% in mesh vs. 12.2% controls). Five patients (3.4%) underwent PSH repair. Median time to radiological and clinical PSH was 8.7 and 14.6 months, respectively. No definite intraoperative or long-term mesh-related complications were reported. The 2- and 3-year PSH-free survivals in the mesh and control groups were 73% vs. 67% and 65% vs. 56%, respectively (log-rank p=0.71) (Figure 1). On multivariable Cox regression analysis, prior abdominopelvic radiation (HR 7.0, p=0.004) and higher postoperative body mass index (HR 1.07 for each unit, p=0.04) had significant association with increased risk of PSH (Figure 2). CONCLUSIONS: Prophylactic biologic mesh at the time of ileal conduit construction is safe, but it may not have a significant protective effect following surgery. Most PSHs occur within 2 years following surgery but longer-term follow-up is still warranted. Download PPTDownload PPT Source of Funding: None © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e455 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Hooman Djaladat More articles by this author Alireza Ghoreifi More articles by this author Farshad Sheybaee Moghaddam More articles by this author Tapas Tejura More articles by this author Gus Miranda More articles by this author Rene 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 ...