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Prophylactic Use of Biologic Mesh in Ileal Conduit (PUBMIC): A Randomized Clinical Trial.
- Source :
-
The Journal of urology [J Urol] 2024 Jun; Vol. 211 (6), pp. 743-753. Date of Electronic Publication: 2024 Apr 15. - Publication Year :
- 2024
-
Abstract
- Purpose: We assessed the effect of prophylactic biologic mesh on parastomal hernia (PSH) development in patients undergoing cystectomy and ileal conduit (IC).<br />Materials and Methods: This phase 3, randomized, controlled trial (NCT02439060) included 146 patients who underwent cystectomy and IC at the University of Southern California between 2015 and 2021. Follow-ups were physical exam and CT every 4 to 6 months up to 2 years. Patients were randomized 1:1 to receive FlexHD prophylactic biological mesh using sublay intraperitoneal technique vs standard IC. The primary end point was time to radiological PSH, and secondary outcomes included clinical PSH with/without surgical intervention and mesh-related complications.<br />Results: The 2 arms were similar in terms of baseline clinical features. All surgeries and mesh placements were performed without any intraoperative complications. Median operative time was 31 minutes longer in patients who received mesh, yet with no statistically significant difference (363 vs 332 minutes, P = .16). With a median follow-up of 24 months, radiological and clinical PSHs were detected in 37 (18 mesh recipients vs 19 controls) and 16 (8 subjects in both arms) patients, with a median time to radiological and clinical PSH of 8.3 and 15.5 months, respectively. No definite mesh-related adverse events were reported. Five patients (3 in the mesh and 2 in the control arm) required surgical PSH repair. Radiological PSH-free survival rates in the mesh and control groups were 74% vs 75% at 1 year and 69% vs 62% at 2 years.<br />Conclusions: Implementation of biologic mesh at the time of IC construction is safe without significant protective effects within 2 years following surgery.
- Subjects :
- Humans
Male
Female
Aged
Middle Aged
Incisional Hernia prevention & control
Urinary Bladder Neoplasms surgery
Follow-Up Studies
Postoperative Complications prevention & control
Postoperative Complications epidemiology
Postoperative Complications etiology
Prophylactic Surgical Procedures methods
Surgical Mesh adverse effects
Urinary Diversion methods
Cystectomy methods
Cystectomy adverse effects
Subjects
Details
- Language :
- English
- ISSN :
- 1527-3792
- Volume :
- 211
- Issue :
- 6
- Database :
- MEDLINE
- Journal :
- The Journal of urology
- Publication Type :
- Academic Journal
- Accession number :
- 38620056
- Full Text :
- https://doi.org/10.1097/JU.0000000000003902