Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy

NCT03469362 | Completed DMC

• 1 other identifier: 20170004
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Outcome Measures

Primary Outcomes (1)

• 90-day Major Post-Operative Complication Rate

  Major complication rate at 90-days from RARC + urinary diversion using the modified Clavien-Dindo grading system. Major complication is defined as Clavien-Dindo Grade ≥ 3.

  90 days

Secondary Outcomes (12)

• 90-day Any Post-Operative Complication Rate

  90 days

• Length of Hospital Stay in ECD vs ICD Study Participants

  About 2 weeks

• 90-day Readmission Rate

  90 days

• Rate of Return to the Operating room within 90 days

  Up to 90 days

• Mortality Rate at 90 days

  90 days

Study Arms (2)

Extracorporeal Urinary Diversion (ECD)

EXPERIMENTAL

Participants will be randomized to receiving ECD after scheduled Robotic Assisted Radical Cystectomy (RARC).

Procedure: Extracorporeal Urinary Diversion

Intracorporal Urinary Diversion (ICD)

EXPERIMENTAL

Participants will be randomized to receiving ICD after scheduled Robotic Assisted Radical Cystectomy (RARC).

Procedure: Intracorporal Urinary Diversion

Interventions

Extracorporeal Urinary Diversion PROCEDURE

Extra-corporeal urinary diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit by hand.

Also known as: ECD

Extracorporeal Urinary Diversion (ECD)

Intracorporal Urinary Diversion PROCEDURE

Intracorporal Urinary Diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit using the Da Vinci robot.

Also known as: ICD

Intracorporal Urinary Diversion (ICD)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Mark L Gonzalgo, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 19, 2018
• Study Start: April 25, 2018
• Primary Completion: August 20, 2024
• Study Completion: September 11, 2024
• Last Updated: March 25, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)