This trial studies how well urinary diversion techniques (intra-corporal versus extra-corporal) work after robot assisted radical cystectomy (surgery to remove all of the bladder as well as nearby tissues and organs) for the treatment of bladder cancer. After removal of the bladder, a conduit is made from a segment of the small intestine so that urine can pass outside the body and into an appliance bag. Intra-corporal urinary diversion means most of the suturing to close the surgical wound is done inside of the body, while extra-corporal urinary diversion means most of the suturing is done outside of the body. This study is being done to determine whether intra-corporal urinary diversion provides a difference in complication rates within 90 days after surgery compared to extra-corporal urinary diversion.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03469362.
PRIMARY OBJECTIVE:
I. To determine whether robot assisted radical cystectomy (RARC) followed by intra-corporal diversion (ICD) provides superior postoperative outcomes compared to RARC followed by extra-corporal diversion (ECD), resulting in a 20% reduction of 90-day major postoperative complications.
SECONDARY OBJECTIVES:
I. To evaluate 90-day (any) postoperative complications between ICD versus (vs.) ECD.
II. To evaluate length of stay between ICD vs ECD.
III. To evaluate the 90-day readmission rate.
IV. To evaluate rate of death at 90 days.
V. To evaluate bowel specific complications (including incidence of mechanical bowel obstruction, anastomotic leaks, and surgical site infections).
VI. To evaluate functional independence as measured by patient reported scores of Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL's), hand grip strength test, and timed up and go walking test.
VII. To evaluate general health-related quality of life measured by the Short Form 8 (SF-8) and bladder cancer-specific quality of life as measured by the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index (FACT-VCI).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo ICD after RARC.
ARM II: Patients undergo ECD after RARC.
After completion of study treatment, patients are followed up at 3, 6, 12, 24, and 36 months post surgery.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorMark L. Gonzalgo
