None listed
Conditions
Brief summary
UDIVERT is a study designed to evaluate the outcomes following robotic removal of the bladder (radical cystectomy) for bladder cancer. The procedure is split into two main parts. Firstly, there is removal of the bladder +/- prostate (male) or gynaecological organs (female) as well as lymph nodes. The second part involves reconstruction of a new urinary tract (urinary diversion) using a section of small bowel attached to the ureters to drain urine produced by the kidneys. The main objective is to investigate whether performing the urinary tract reconstruction part of the operation is better if done fully robotically (intracorporeal), or whether it is preferable to make a larger incision and perform this using a traditional open surgery approach (extracorporeal). Who is it for? You may be eligible for this study if you are aged between 18 and 80 years, and are undergoing an elective robotic radical cystectomy for bladder cancer or for a non-functioning urinary tract due to bladder cancer treatment. Study details All participants will undergo a cystectomy using robotic surgical techniques. However, participants will be randomised (i.e. allocated by chance) to either undergo urinary diversion robotically or using an open approach. For the robotic surgery (intracorporeal) group, this will involve using the robotic equipment to perform the diversion within the abdomen without making another incision, and is anticipated to take approximately 6 hours to complete. For the open surgery (extracorporeal) group, this will involve performing the urinary diversion from outside the body through an incision in the abdominal wall (known as open method), and is anticipated to take approximately 5 hours to complete. For all participants, the duration of hospital stay after completion of the procedure will be recorded. Participants will additionally be assessed for their recovery, functional outcomes, and quality of life using a number of questionnaires for up to 1 year post-procedure. Lastly, the cost of the two different approaches will be assessed. It is hoped that this study may demonstrate that intracorporeal urinary diversion following robotic cystectomy reduces hospital length of stay, and improves recovery and quality of life compared to an extracorporeal approach.
Interventions
The intervention in the UDIVERT randomised trial is intra-corporeal urinary diversion during a Robot-Assisted Radical Cystectomy surgical procedure. Intra-corporeal urinary diversion (ICUD) involves performing diversion using the Da Vinci Xi Surgical Robot's arms internally, within the body. Urinary diversion involves a 15cm segment of small bowel (ileum) which is resected but kept on the mesentery to maintain its blood supply. The cut ends of the ileum are joined back together to reform continu
The intervention in the UDIVERT randomised trial is intra-corporeal urinary diversion during a Robot-Assisted Radical Cystectomy surgical procedure. Intra-corporeal urinary diversion (ICUD) involves performing diversion using the Da Vinci Xi Surgical Robot's arms internally, within the body. Urinary diversion involves a 15cm segment of small bowel (ileum) which is resected but kept on the mesentery to maintain its blood supply. The cut ends of the ileum are joined back together to reform continuity of the small bowel. Each ureter is joined to the segment of ileum over a stent (uretero-ileal anastomosis) which remains inside the body. The distal end of the ileal segment is brought out through the abdominal wall as a spouted stoma using sutures to adhere the bowel to the skin outside the body. For ICUD, a laparoscopic stapler device is used to perform the preparation of the segment of ileum. The only incisions required for this arm of the trial are for four robotic ports (8mm), placed under vision and a further two assistant ports (12 and 15mm) are inserted. It is expected this procedure will take around 6 hours to perform in entirety. All surgeons performing the interventions are experienced robotic and urological surgeons. All operations are audited as part of the Trial. This is to collect pertinent data, but also to ensure compliance to arm of intervention.
Sponsors
Department of Urology Royal Prince Alfred Hospital (RPAH)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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)
Outcome results
None listed