Intracorporeal vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy

NCT ID: NCT03469362

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-25
• Study Completion Date: 2024-09-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Extracorporeal Urinary Diversion (ECD)

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

Group Type: EXPERIMENTAL

Extracorporeal Urinary Diversion

Intervention Type: PROCEDURE

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

Intracorporal Urinary Diversion (ICD)

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

Group Type: EXPERIMENTAL

Intracorporal Urinary Diversion

Intervention Type: 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.

Interventions

Extracorporeal Urinary Diversion

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

Intervention Type: PROCEDURE

Intracorporal Urinary Diversion

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

Intervention Type: PROCEDURE

Other Intervention Names

ECD; ICD

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Mark L. Gonzalgo, MD, PhD

Professor of Clinical

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark L Gonzalgo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20170004

Identifier Type: -

Identifier Source: org_study_id