Randomised Study assessing reconstruction of the urinary tract via robotic (intracorporeal) or open (extracorporeal) method during removal of the bladder.
- Conditions
- Radical CystectomyCancer - BladderSurgery - Other surgeryRenal and Urogenital - Other renal and urogenital disorders
- Registration Number
- ACTRN12622000614796
- Lead Sponsor
- Department of Urology Royal Prince Alfred Hospital (RPAH)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 72
To be eligible to enter the study all patients must satisfy the following criteria:
1. Adult aged 18 to 80 years of age
2. Undergoing Robot-Assisted Radical Cystectomy (RARC) for bladder cancer (and requiring either ileal conduit or neobladder) or RARC for non-functioning lower urinary tract requiring urinary diversion
3. Oncologically suitable for robotic cystectomy ie localised bladder cancer
Non-invasive disease - Certain high risk high grade NMIBC T1 disease
MIBC T2-T4N1M0
4. Clinically suitable for robotic cystectomy ie deemed surgical fit for a major operation as deemed by anaesthetic pre-operative assessment
5. Cognitively able to give written informed consent for participation
6. Elective procedure
7. Salvage cystectomy cases will be included where primary treatment with radiation has failed and the patient is oncologically and clinically suitable for robotic cystectomy.
8. Concomitant urethrectomy patients will be included
Patients will be excluded if they present the following exclusion criteria:
1. The patient lacks the ability to consent for themselves
2. Patient or tumour factors precluding robotic surgery (including not medically fit for surgery, extensive previous abdominal surgery, metastatic disease or potentially unresectable locally advanced disease)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method