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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02665156 |
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Date of registration:
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19/01/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy
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Scientific title:
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Phase 2 Clinical Trial to Assess Time Efficiency of Intracorporeal Orthotopic Diversion With Robotic Staplers After Robot Assisted Radical Cystectomy |
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Date of first enrolment:
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January 2016 |
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Target sample size:
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33 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02665156 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Italy
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Contacts
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Name:
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Giuseppe Simone, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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"Regina Elena" National Cancer Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Pathologically confirmed muscle invasive bladder cancer or recurrent high grade
urothelial carcinoma (BCG failures)
Exclusion Criteria:
- All absoulte contraindications to orthotopic neobladder;
- Anesthesiologic contraindications to penumoeperitoneum and steep Trendelenburg
position.
- cT4 disease;
- clinical evidence of metastases (cM1) outside the pelvis.
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Surgical Staplers
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Cystectomy
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Robotic Surgical Procedures
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Intervention(s)
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Procedure: Intracorporeal stapled neobladder using robotic staplers
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Primary Outcome(s)
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Improving time efficiency, achieving a total operative <5 hrs in 80% of cases (28/33)
[Time Frame: 1 yr]
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Secondary Outcome(s)
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Neobladder stone formation
[Time Frame: 1-yr]
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Perioperative complications
[Time Frame: 6 months]
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Cost analysis
[Time Frame: 1-yr]
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Readmission rate
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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