Randomized Trial Comparing Robotic and Open Radical Cystectomy

Bladder Cancer Clinical Trial

Official title:

A Prospective, Randomized Trial Comparing Robotic and Open Radical Cystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076387
• Other study ID #: 10-016
• Status: Completed
• Phase: Phase 3
• Start date: February 2010
• Est. completion date: March 12, 2020

Study information

• Verified date: March 2020
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if using robotic surgical technology during bladder cancer surgery helps to reduce complications during and after the surgery. The removal of the bladder and lymph nodes will be done by a robotic or by an open technique. It may be a Robotic-assisted Radical Cystectomy (RARC) and Pelvic Lymph Node Dissection. Or it may be an Open Radical Cystectomy (ORC) and Pelvic Lymph Node Dissection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: March 12, 2020
• Est. primary completion date: March 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years.

• Scheduled for radical cystectomy at MSKCC

Exclusion Criteria:

• Prior pelvic or abdominal radiation therapy;

• Prior extensive open abdominal surgery, defined by the discretion of the attending surgeon

• Any clinical contraindication for Trendelenburg positioning

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• open radical cystectomy
Open radical cystectomy, pelvic lymph node dissection and open urinary diversion.
• robotic-assisted radical cystectomy
Robotic radical cystectomy, pelvic lymph node dissection and open urinary diversion. Robotic radical cystectomy is routinely performed by robotically trained and experienced minimally invasive surgeons.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare surgical complications of robotic-assisted radical cystectomy and open radical cystectomy.		intraoperative and 90-day postoperative period
Secondary	To examine clinical and pathological outcomes of robotic-assisted radical cystectomy and open radical cystectomy.		2 years
Secondary	Intra-operative performance (surgical time, blood loss)		time from anesthesia induction to final skin closure
Secondary	Pathologic findings, including the stage specific, soft tissue surgical margin rate and number of lymph nodes removed.		1.5 years
Secondary	Bladder cancer recurrence (local, upper tract and distant disease)		2 years
Secondary	complications grade 2-5	A secondary analysis will be used to determine if the total burden of grade 2-5 complications in the robotic arm is different from the open arm.	2 years
Secondary	complication grade 3-5	Determine if there is a difference in either the number of patients with grade 3-5 complication or the total number of grade 3-5 complication in the two arms of the study.	2 years

External Links

•   Memorial Sloan Kettering Cancer Center