PD34-08 A PROSPECTIVE RANDOMIZED PHASE 3 TRIAL EVALUATING BENEFITS OF PERISTOMAL MESH PLACEMENT AT THE TIME OF RADICAL CYSTECTOMY AND ILEAL CONDUIT FORMATION

You have accessJournal of UrologyBladder Cancer: Invasive III (PD34)1 May 2024PD34-08 A PROSPECTIVE RANDOMIZED PHASE 3 TRIAL EVALUATING BENEFITS OF PERISTOMAL MESH PLACEMENT AT THE TIME OF RADICAL CYSTECTOMY AND ILEAL CONDUIT FORMATION Timothy F. Donahue, Melissa Assel, Kelly Pekala, Alex Doudt, Jacob Tallman, Eugene Pietzak, Eugene K. Cha, Guido Dalbagni, Melissa McCarter, Nicole Liso, Andrew Vickers, Alberto Vargas, Stephen Fleming, and Bernard H. Bochner Timothy F. DonahueTimothy F. Donahue , Melissa AsselMelissa Assel , Kelly PekalaKelly Pekala , Alex DoudtAlex Doudt , Jacob TallmanJacob Tallman , Eugene PietzakEugene Pietzak , Eugene K. ChaEugene K. Cha , Guido DalbagniGuido Dalbagni , Melissa McCarterMelissa McCarter , Nicole LisoNicole Liso , Andrew VickersAndrew Vickers , Alberto VargasAlberto Vargas , Stephen FlemingStephen Fleming , and Bernard H. BochnerBernard H. Bochner View All Author Informationhttps://doi.org/10.1097/01.JU.0001008768.36634.79.08AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Stomal complications remain one of the major challenges with ileal conduit (IC) urinary diversion and have been shown to negatively impact on quality of life after cystectomy (RC). Parastomal hernias (PH) develop in up to half of patients after stoma formation, 30%-75% are symptomatic, and up to 1/3 of patients require surgical repair. Local tissue repair has recurrence rates as high as 76% and relocation of the stoma requires closure of the original stoma defect, placing both sites at risk for hernias in 60% of patients. We conducted a randomized trial of prophylactic mesh placement at the time of conduit formation to reduce the likelihood of developing PH. METHODS: The primary aim of this study was to test the hypothesis that the proportion of patients who experience a radiographic PH within 2 years of RC and IC differs among patients who were randomized to receive prophylactic mesh versus standard stoma formation. An absolute difference of 22% was chosen as this would represent a clinically meaningful difference between groups. We used a Cochran-Mantel-Haenszel test after adjusting for the effect of BMI and surgeon to determine the association between treatment arm and the proportion of patients who experience a radiographic PH, with a 2-sided α level of 0.05. The null hypothesis was that the rate of radiographic PH is equivalent for both treatment arms (i.e., the radiographic PH rate in both arms is 48%). Ultrapro semi-absorbable mesh was placed sublay position dorsal to the rectus muscle and anterior to the posterior rectus sheath. RESULTS: Of 178 patients randomized, 8 were found to be ineligible and 10 withdrew consent prior to surgery leaving 160 eligible patients for analysis. The final radiographic assessment for PH was at 24 months. 32 (47%) patients randomized to receive mesh had radiographic evidence of a parastomal hernia versus 23 (33%) patients who did not (risk difference 14%; 95% CI -4.0%, 31%, p=0.14). The overall odds ratio comparing those randomized to mesh versus no mesh was 1.78 (0.89, 3.55). The results were not impacted when stratified by BMI or surgeon, separately (OR 1.74; 95% CI 0.86, 3.51; p=0.2 and 1.69; 95% CI 0.83, 3.41; p=0.2). CONCLUSIONS: The results of our study exclude a clinically relevant benefit of peristomal mesh placement at the time RC to reduce PH. Based on these findings mesh at the time of conduit creation should not be used to avoid parastomal hernia formation. Source of Funding: Internal funds; MSKCC © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e721 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Timothy F. Donahue More articles by this author Melissa Assel More articles by this author Kelly Pekala More articles by this author Alex Doudt More articles by this author Jacob Tallman More articles by this author Eugene Pietzak More articles by this author Eugene K. Cha More articles by this author Guido Dalbagni More articles by this author Melissa McCarter More articles by this author Nicole Liso More articles by this author Andrew Vickers More articles by this author Alberto Vargas More articles by this author Stephen Fleming More articles by this author Bernard H. Bochner More articles by this author Expand All Advertisement PDF downloadLoading ...