Clinical trial NCT03469362: Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy
Official title: Randomized Clinical Trial of Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2018-03-19
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Intracorporeal urinary diversion (ICD) provides superior postoperative outcomes compared to extracorporeal urinary diversion (ECD). The investigators' hypothesis that ICD may provide clinical benefit is based on principles of less bowel and ureteral handling, superior operating room workflow, less exposure to the external environment, and optimal visualization with ICD while utilizing a smaller incision compared to ECD. ICD should have less bowel-related complications, lower pain scores allowing patients to be discharged from the hospital sooner and regain functional independence more quickly.


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven urothelial cancer being considered for RARC.
* Clinical stage T1-T4, N0-1, M0 or refractory carcinoma in situ.
* Subject must be already scheduled to have a RARC at the discretion of the surgeon and with the patient's agreement.

Exclusion Criteria:

* Inability to give informed consent
* Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
* At the discretion of the treating surgeon, any pre-existing condition such as severe chronic obstructive pulmonary disease that precludes a safe initiation or maintenance of pneumoperitoneum over a prolonged period of time and during surgery.
* Age \<18 or \>99 years.

Primary outcomes:
measure: 90-day Major Post-Operative Complication Rate
timeFrame: 90 days
Secondary outcomes:
measure: 90-day Any Post-Operative Complication Rate
timeFrame: 90 days
measure: Length of Hospital Stay in ECD vs ICD Study Participants
timeFrame: About 2 weeks
measure: 90-day Readmission Rate
timeFrame: 90 days
measure: Rate of Return to the Operating room within 90 days
timeFrame: Up to 90 days
measure: Mortality Rate at 90 days
timeFrame: 90 days
measure: Rate of Bowel-Specific Complications
timeFrame: Up to 36 months
measure: Functional Independence Recovery as measured by the ADL Questionnaire
timeFrame: Up to 36 months
measure: Functional Independence Recovery as measured by the IADL Questionnaire
timeFrame: Up to 36 months
measure: Functional Independence Recovery as measured by the Hand Grip Strength Test.
timeFrame: Up to 36 months
measure: Functional Independence Recovery as measured by the Timed Up and Go (TUG) Walking Test
timeFrame: Up to 36 months
measure: Health-Related Quality of Life (HRQoL) as assessed by SF-8 Health Survey
timeFrame: Up to 36 months
measure: HRQoL as assessed by the FACT-VCI Questionnaire
timeFrame: Up to 36 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Mark L Gonzalgo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: