None listed
Conditions
Brief summary
The purposes of this study is to assess the urinary function of men undergoing a prostatectomy with and without a 'RoboSling', which is a thin piece of the patient's abdominal lining tissue that is stitched to the pubic bone during surgery to support the bladder. Who is it for? You may be eligible for this study if you are aged at least 18 years and are undergoing a prostatectomy for prostate cancer with one of the participating surgeons involved in this study. Study details Participants in this study will be randomised (by chance) into two groups. Both groups will undergo their planed prostatectomy procedure. One group will have a standard procedure, and the other group will have a standard procedure with the creating of a ‘RoboSling’ from their abdominal lining tissue during surgery. All participants will complete a number of questionnaires at 7 timepoints over the weeks and months just prior to and following their surgery. It is intended that this study will help to improve urinary continence in men after prostatectomy surgery in the future.
Interventions
Participants in the intervention group will first complete a baseline questionnaire when they consent to the trial, and undergo pre-operative urinal functional testing by a urologist (including a perineal/pelvic floor ultrasound, uroflow test and urodynamic assessment). They will then proceed to a robotic-assisted radical prostatectomy surgery, incorporating the construction of a retropubic vascularised fascial sling (RoboSling, the 'intervention'), completed by their treating urological surgeon. The RoboSling is created by dissecting a piece of peritoneum (abdominal lining tissue) off f the rear surface of the bladder, which is then brought underneath the bladder to the front, and top corners of the flap stitched upwards under tension to the pubic bone). After surgery, intervention participants will complete a series of 6 post-operative questionnaires at set follow-up timepoints up to one year post-operative when visiting their surgeon for post-operative review/management appointments, and again undergo post-operative urinal functional testing at one-year with a urologist. The control (comparator) group will undergo all these procedures except their surgery will NOT include the construction of a RoboSling.
Sponsors
Study design
Eligibility
Inclusion criteria
To be eligible to enter the study all patients must satisfy the following criteria: 1. Adult men aged 18 years and over 2. Undergoing prostatectomy for prostate cancer at RPA hospital in Sydney, Australia 3. Clinically suitable for robotic prostatectomy 4. Cognitively able to give written informed consent for participation 5. Elective procedure
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