Intracorporeal Vs Extracorporeal Urinary Diversion After Robot Assisted Radical Cystectomy

University of Miami

Status: Completed

Conditions: Bladder Cancer

Treatments: Procedure: Extracorporeal Urinary Diversion; Procedure: Intracorporal Urinary Diversion

Study type: Interventional

Funder types: Other

Identifiers

NCT03469362

20170004

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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38 participants in 2 patient groups

Extracorporeal Urinary Diversion (ECD)

Experimental group

Description:

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

Treatment:

Procedure: Extracorporeal Urinary Diversion

Intracorporal Urinary Diversion (ICD)

Experimental group

Description:

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

Treatment:

Procedure: Intracorporal Urinary Diversion