None listed
Conditions
Brief summary
The purpose of this study is to determine if continuous irrigation of the bladder using sterile water for at least 3 hours is feasible and safe in bladder tumour resection. Who is it for? You may be eligible for this study if you are an adult who is suspected of having bladder cancer. Study details Standard surgery for bladder tumours involves irrigation of the bladder during and after the surgery using sterile saline (salt water). If you participate in this study, you will have sterile water used for this irrigation during and for at least 3 hours after surgery instead. If irrigation using water is found to be feasible and safe, it can then be assessed further to see if it can prevent the bladder cancer. from coming back. This could have a major impact on treating bladder cancer
Interventions
Irrigation of the bladder using water irrigation during (by the surgeon in the operating theatre) and after (by nursing staff on the ward) bladder tumour resection. Duration of water irrigation will be for at least 3 hours, and can continue for longer at the discretion of the treating clinician
Sponsors
Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older 2. Capacity to provide informed consent 3. Suspected bladder cancer on flexible cystoscopy or imaging
Exclusion criteria
1. At risk of water toxicity: a. History of hyponatraemia (serum sodium below normal limits, usually 135 mmol/L) b. Chronic renal impairment (eGFR < 30) c. Congestive cardiac failure (Ejection Fraction < 25%) 2. Suspected or confirmed pregnancy
Outcome results
None listed