NCT03469362Completed
Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy
Randomized Clinical Trial of Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy
Source: ClinicalTrials.gov · Last updated 25 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 38 (actual)
- First submitted
- 6 Mar 2018
- Start date
- 25 Apr 2018
- Primary completion date
- 20 Aug 2024
- Lead sponsor
- University of Miami
- Diseases
- Bladder cancer
- NCT number
- NCT03469362
What you commit to
- Study type: Interventional
- Participants enrolled: 38
- From 25 Apr 2018 to the primary completion date, 20 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
Other illness
- 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
- Age \<18 or \>99 years.
Other
- Inability to give informed consent
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.