Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Status: | Active, not recruiting |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 6/28/2018 |
Start Date: | July 2011 |
End Date: | December 2018 |
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).
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).
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.
We found this trial at
16
sites
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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University of Miami A private research university with more than 15,000 students from around the...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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San Antonio, Texas 78229
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Seattle, Washington 98101
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Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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