KEY TAKEAWAYS
- The trial assessed the efficacy of prophylactic biologic mesh in preventing PSH in pts undergoing cystectomy and ileal conduit.
- The pts were randomized in a 1:1 ratio to receive prophylactic biologic mesh (FlexHD, thickness 2.5 mm) using sublay intraperitoneal technique.
- The initial findings suggest utilizing biologic mesh in ileal conduit construction is safe but offers no significant protection in the first year, yet may be helpful afterward.
The phase III randomized controlled trial enrolled patients (pts) undergoing cystectomy and ileal conduit at USC between 2016 and 2021. The pts were randomly assigned in a 1:1 ratio to receive prophylactic biologic mesh (FlexHD, thickness 2.5 mm) employing sublay intraperitoneal technique. Follow-ups were scheduled every 4-6 months for 2 years. The primary endpoint was radiological assessment (Moreno classification); the secondary endpoint was clinical parastomal hernia (PSH).
The study involved 146 patients, distributed between two groups. Seventy-two individuals received mesh treatment, and 74 were in the control group. The clinical characteristics of both groups were identical, and all surgeries and mesh placements were executed without intraoperative complications. The study has shown that pts receiving mesh had 31 minutes longer median operative time. There was no significant difference between the mesh and control groups in postoperative wound/stoma and infectious complications (7% vs. 8%, and 26% vs. 22%, respectively).
Over 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). The median radiological and clinical PSH time was 8.5 and 15.6 months, respectively. Mesh usage did not result in any adverse incidents. As per multivariable Cox regression analysis, prior radiation (HR 3.6, p=0.02) and pathological T stage>2 (HR 2, p=0.06) were associated with increased risk of PSH. The mesh group had higher PSH-free survival rates than the control group in every year analyzed. At 1 year, the mesh group had a 77% rate while the control group had 76%. At 2 years, it was 72% vs. 62%; at 3 years, it was 58% vs. 44%.
According to the initial findings utilizing biologic mesh in ileal conduit construction is safe but offers no significant protection in the first year. It may help prevent postoperative hernias in the future.
Source: https://www.auajournals.org/doi/10.1097/JU.0000000000003323.04
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02439060
Djaladat, Hooman; Ghoreifi, Alireza; Tejura, Tapas; Miranda, Gus; Cai, Jie; Sotelo, Ileana Aldana; Gill, Inderbir; Bhanvadia, Sumeet; Schuckman, Anne; Desai, Mihir; Aron, Monish; Daneshmand, Siamak; Duddalwar, Vinay MP65-04 PROPHYLACTIC USE OF BIOLOGIC MESH IN ILEAL CONDUIT (PUBMIC): INITIAL REPORT OF A RANDOMIZED CONTROLLED TRIAL, Journal of Urology: April 2023 – Volume 209 – Issue Supplement 4
doi: 10.1097/JU.0000000000003323.04
