Introduction: Parastomal hernia (PSH) is a common complication in patients receiving ileal conduit urinary diversion after radical cystectomy. To validate our previous finding that extraperitonealization of ileal conduit (modified ileal conduit) decreases incidence of PSH after ileal conduit diversion. Methods: This is a single-center, randomized controlled clinical trial (clinical trials.gov, NCT03822234). Between January, 2019 and March, 2020, 104 consecutive patients undergoing radical cystectomy at Sun Yat-sen University Cancer Center were randomized 1:1 to receive either modified ileal conduit (n = 52) or conventional ileal conduit (n = 52). One group received extraperitonealization of ileal conduit, the other received conventional ileal conduit. Primary endpoint was incidence of radiological PSH at 24 months post surgery. Secondary endpoints were incidence of stomal complications (retraction, stenosis, and prolapse) at 24 months. Other complications related to surgery were also recorded. Results: Incidence of radiological PSH was lower in modified ileal conduit patients than in conventional ileal conduit patients (11.5% [6/52] vs. 28.8% [15/52]; p = 0.028) after a median follow-up of 32 months, corresponding to a hazard ratio of 0.375 (95% CI: 0.146-0.967, p = 0.043) in the modified conduit group. No stomal retraction, stenosis or prolapse complications occurred. Median operating time was comparable between the groups. Early surgery-related complications were less in modified conduit patients; late complications were similar in the two groups. Conclusions: The results support our previous finding that extraperitonealization of ileal conduit is effective for reducing risk of PSH in ileal conduit diversion patients. Further multicenter controlled clinical trials on large samples (including obese patients) are needed. SOURCE OF Funding: Without Source of Funding
