Patients who are recruited will undergo either open or robotic radical cystectomy. In open radical cystectomy, the surgeon cuts into the lower abdomen to expose the urinary tract in order to remove the bladder. In robotic radical cystectomy, small cuts are made in the abdomen into which a scope is inserted; with robotic help, the surgeon removes the bladder. It is currently unknown which approach results in fewer complications, better quality of life, and faster recovery time.
Patients are eligible for the study if they are indicated for radical cystectomy, have Tis-T3 urothelial cancer, and meet surgical candidate criteria. Exclusion factors include having a bulky lymphadenopathy, prior pelvic radiation, or uncontrolled coagulopathy.
The primary outcome measure is change in patient-reported quality of life, as reported using the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30, 1 month post surgery. The secondary outcome measure is change in erectile dysfunction, as measured by the Sexual Health Inventory For Men , over a follow-up of up to 12 months.
Recruitment ends on Oct. 12, 2019, and the estimated study completion date is Oct. 12, 2020. About 208 participants are expected to be included.
Find more information on the study page at.