Randomised Study assessing reconstruction of the urinary tract via robotic (intracorporeal) or open (extracorporeal) method during removal of the bladder.
UDIVERT: Randomised study assessing the effect of intracorporeal versus extracorporeal urinary diversion on hospital length of stay in patients undergoing robotic assisted cystectomy
Department of Urology Royal Prince Alfred Hospital (RPAH)
72 participants
Oct 28, 2022
Interventional
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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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 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.
Locations(5)
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ACTRN12622000614796