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

Abstract

<h4>Purpose</h4>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.<h4>Materials and methods</h4>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.<h4>Results</h4>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%; <i>P</i> = .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; <i>P</i> = .2; by surgeon: OR 1.69; 95% CI: 0.83, 3.41; <i>P</i> = .2).<h4>Conclusions</h4>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.