Stomal complications following ileal conduit (IC) urinary diversion are challenging and can negatively impact quality of life after radical cystectomy. Parastomal hernias (PH) develop in up to half of patients; 30%-75% are symptomatic, and up to 1/3 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. Primary aim of this randomized phase 3 trial was to test whether prophylactic placement of a parastomal mesh at IC formation reduced radiographic PH (rPH) rate compared with standard techniques without mesh; final rPH assessment was at 24 months. Ultrapro semi-absorbable mesh was placed in a sublay position dorsal to rectus muscle and anterior to posterior rectus sheath. Of 178 patients randomized, 137 were eligible for analysis. Thirty-two of the 68 (47%) evaluable patients in the mesh arm had rPH versus 23/69 (33%) patients in the non-mesh arm (risk difference 14%; 95% CI -4.0%, 31%; p=0.14). The overall odds ratio (OR) comparing those randomized to mesh versus no mesh was 1.78 (95% CI 0.89, 3.55). Results were not meaningfully impacted when stratified by BMI or surgeon, separately (by BMI: OR 1.74; 95% CI 0.86, 3.51; p=0.2; by surgeon: OR 1.69; 95% CI 0.83, 3.41; p=0.2). 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.
Donahue et al. (Fri,) studied this question.