N/A
N=350
Open Vs Robotic-Assisted Radical Cystectomy: A Randomized Trial
Bladder Cancer Requiring Cystectomy
Bottom Line
View on ClinicalTrials.gov: NCT01157676 ↗Enrolled (actual)
350
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Percentage of Participants With 2-year Progression Free Survival (PFS) — 71.6; 72.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Open radical cystectomy (Procedure); Robotic assisted radical cystectomy (Procedure); DaVinci robot (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Miami
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With 2-year Progression Free Survival (PFS) |
71.6; 72.3 | — |
| PRIMARY Number of Participants With Positive Margins |
7; 9; 5; 6; 4; 3 | — |
| PRIMARY Number of Participants Requiring Lymph Node Dissection |
84; 76; 68; 73 | — |
| PRIMARY Quality of Life (QOL) Outcomes |
120.9; 120.1; 125.2; 122.8; 127.5; 126.0 | — |
| PRIMARY Number of Participants With Post-surgical Complications |
47; 49; 20; 24; 51; 44 | — |
| PRIMARY Amount of Estimated Blood Loss (EBL) in ml |
700; 300 | — |
| PRIMARY Number of Participants Requiring Blood Transfusion |
65; 35; 46; 18; 54; 33 | — |
| PRIMARY Number of Days of Post Operative Length of Hospital Stay |
7; 6 | — |
| PRIMARY Length of Operative Time |
361; 428 | — |
| PRIMARY Laboratory Values |
12.84; 13.11; 11.19; 11.62; 12.05; 12.17 | — |
| PRIMARY Measures of Functional Independence as Assessed by the Activities of Daily Living (ADL) Questionnaire |
7.2; 7.2; 7.8; 7.6; 7.5; 7.3 | — |
| PRIMARY Percentage of Participants With 3-year Progression Free Survival (PFS) |
65.4; 68.4 | — |
| PRIMARY Quality of Life (QOL) Outcomes as Assessed by the Short Form 8 (SF-8) Questionnaire |
45.3; 46.1; 46.2; 45.7; 49.6; 47.5 | — |
| PRIMARY Total Number of Participants Requiring Intra-operative Fluid Requirement |
46; 18 | — |
| PRIMARY Total Postoperative Analgesic Requirements |
157.7; 167.2 | — |
| PRIMARY Creatinine Value. |
1.17; 1.12; 1.27; 1.28; 1.16; 1.26 | — |
| PRIMARY Measures of Functional Independence as Assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire |
8.8; 8.5; 10.8; 10.3; 9.5; 8.9 | — |
| PRIMARY Performance Related Measures of Functional Independence as Assessed by the Hand Grip Strength Test |
37.4; 36.2; 34.5; 34.1; 35.1; 34.2 | — |
| PRIMARY Performance Related Measures of Functional Independence as Assessed by the Time Up and Go (TUG) Walking Test |
12.5; 11.7; 13.6; 13.1; 12.8; 11.2 | — |
| PRIMARY Quality of Life (QOL) Outcomes as Assessed by the Functional Assessment of Cancer Therapy - Vanderbilt Cystectomy Index (FACT-VCI) Questionnaire |
23.4; 22.9; 22.8; 23.2; 23.9; 23.2 | — |
| SECONDARY Cost |
— | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- Patient must have biopsy proven bladder cancer. Official pathology report reviewed at the participating institution is required.
- Bladder cancer must be clinical stage T1-T4, N0-1, M0. (AJCC 7th edition) or refractory cis (carcinoma in situ).
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 99 years.
- Pregnancy.
Data sourced from ClinicalTrials.gov (NCT01157676). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.