Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial

University of Miami

Status: Completed

Conditions: Bladder Cancer Requiring Cystectomy

Treatments: Procedure: Robotic assisted radical cystectomy; Procedure: Open radical cystectomy; Device: DaVinci robot

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01157676

20120408

36911 (Other Identifier)

R01CA155388 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a multi-institutional, randomized trial evaluating oncologic, perioperative, and functional outcomes following two standard care procedures for radical cystectomy. The participants will have one of the standard care procedures as part of their care. The two procedures that will be followed are open radical cystectomy and robotic assisted radical cystectomy (RARC). Open cystectomy is considered to be the more traditional approach. While newer, RARC is considered to be equivalent to open surgery when it is performed by a trained robotics surgeon. The reported complication rates of RARC appear comparable to open surgery. This means there is no significant difference in the risk between the two standard procedures. However, despite these potential advantages, true comparison between the open and robotic technique with regards to long term cancer related and functional outcomes has not been accomplished because previous studies did not compare patients of equal health status. The researchers hope to learn whether or not patients undergoing RARC recover more quickly than or at the same rate as patients undergoing an open radical cystectomy while having non inferior cancer related outcomes. This study is funded by the National Institutes of Health (NIH).

Enrollment: 350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient must have biopsy proven bladder cancer. Official pathology report reviewed at the participating institution is required.
2. Bladder cancer must be clinical stage T1-T4, N0-1, M0. (AJCC 7th edition) or refractory cis (carcinoma in situ).

Exclusion criteria

1. Inability to give informed consent.
2. Prior major abdominal and pelvic open surgical procedures that would preclude a safe robotic approach, as determined by the treating surgeon.
3. 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.
4. Age <18 or >99 years.
5. Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Open cystectomy

Active Comparator group

Description:

Open cystectomy performed using an incision made just above or at the level of umbilicus to the pubic symphysis.

Treatment:

Procedure: Open radical cystectomy

Robotic assisted radical cystectomy

Active Comparator group

Description:

Robotic assisted Radical Cystectomy (RARC) is accomplished by a robot assisted laparoscopic approach.

Treatment:

Procedure: Robotic assisted radical cystectomy

Device: DaVinci robot