Evaluating Benefits of Peristomal Mesh Placement at the Time of Radical Cystectomy and Ileal Conduit Formation: A Phase 3, Randomized Controlled Trial

Abstract

Purpose: Stomal complications after ileal conduit urinary diversion are challenging and can negatively affect quality of life after radical cystectomy. Parastomal hernias (PHs) develop in up to half of patients; 30% to 75% are symptomatic, and up to one-third require surgical repair. Recurrence rates after local tissue repair are high, and relocation of the stoma requires closure of the original defect, placing both sites at risk for hernias.

Materials and methods: The primary aim of this randomized phase 3 trial was to test whether prophylactic placement of a parastomal mesh at ileal conduit formation reduced radiographic PH (rPH) rate compared with standard techniques without mesh; final rPH assessment was at 24 months. Ultrapro semiabsorbable mesh was placed in a sublay position dorsal to rectus muscle and anterior to posterior rectus sheath.

Results: Of 178 patients randomized, 137 were eligible for analysis. Thirty-two of the 68 (47%) evaluable patients in the mesh arm had rPH vs 23/69 (33%) patients in the nonmesh arm (risk difference 14%; 95% CI: -4.0%, 31%; P = .14). The overall odds ratio (OR) comparing those randomized to mesh vs no mesh was 1.78 (95% CI: 0.89, 3.55). The results were not meaningfully affected when stratified by BMI or surgeon, separately (by BMI: OR 1.74; 95% CI: 0.86, 3.51; P = .2; by surgeon: OR 1.69; 95% CI: 0.83, 3.41; P = .2).

Conclusions: We were unable to identify a clinical benefit to prophylactic parastomal mesh placement. Based on these findings, mesh at the time of conduit creation should not be used to avoid PH formation.

Keywords: cystectomy; incisional hernia; postoperative complications; surgical mesh; urinary diversion.