Safety of decreasing ureteral stent duration following radical cystectomy.
Hamza Beano, Jiaxian He, Caitlin Hensel...
https://pubmed.ncbi.nlm.nih.gov/32303901Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06595446
A Feasibility Randomized Controlled Trial Evaluating Early vs Late Stent Removal Following Radical Cystectomy and Ileal Conduit Formation for Bladder Cancer
Led by Western University, Canada · Updated on 2025-04-04
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Bladder cancer is a common type of cancer, especially in men, and most cases are non-muscle invasive at diagnosis. When it progresses to muscle-invasive bladder cancer, treatment usually involves chemotherapy followed by surgery called radical cystectomy with urinary diversion. Despite surgical advances, complications after this surgery remain frequent. The role and timing of ureteric stenting during this surgery to prevent urinary leakage and obstruction is uncertain, and prior studies have shown mixed results regarding its benefits and risks. This study is a randomized trial comparing early versus late removal of ureteral JJ stents after radical cystectomy and ileal conduit formation. Participants will be assigned to either have their stents removed early, between 5 and 7 days after surgery, or late, between 4 and 6 weeks after surgery. The study aims to assess the feasibility of conducting a larger definitive trial by evaluating complication rates and other outcomes related to the timing of stent removal. Participants will be monitored for complications within 30 days, 90 days, and up to one year after surgery. The study will also track readmission rates and feasibility outcomes over one year. Researchers will collect data on surgical complications and recovery, with no blinding involved. The total duration of participation varies, with follow-up visits to assess the effects of early versus late stent removal on patient outcomes.
CONDITIONS
Brief Title
A Feasibility Randomized Trial Evaluating Early vs Late Stent Removal Following Radical Cystectomy and Ileal Conduit Formation for Bladder Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients (18 years or older) undergoing radical cystectomy and ileal conduit formation for bladder cancer
- Able to give informed written consent to participate.
You will not qualify if you...
- Treatment without curative intent (cT4b, salvage or palliative cystectomies)
- Patients undergoing alternative forms of urinary diversion (e.g. continent cutaneous urinary diversion or orthotopic neobladder formation)
- Patients previously received abdominal/pelvic radiotherapy
- Patients with concomitant upper urinary tract cancer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Hospital stay duration as determined by clinical care
Participants undergo radical cystectomy and ileal conduit formation surgery followed by immediate post-operative care.
Treatment
Duration - From 5 days up to 6 weeks after surgery
Participants have ureteral JJ stents removed either early (5-7 days) or late (4-6 weeks) after surgery depending on their assigned group.
1 to 2 visits for stent removal depending on group assignment
Post-operative Follow-up
Duration - Up to 1 year after surgery
Participants are monitored for complications and recovery after stent removal for up to 1 year.
Follow-up visits to monitor recovery and complications as scheduled
Trial Site Locations
Total: 1 location
1
Victoria Hospital
London, Ontario, Canada
Actively Recruiting
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Research Team
K
Kaydee Connors, BSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Ureteral stents cannot decrease the incidence of ureteroileal anastomotic stricture and leakage: A systematic review and meta-analysis.
Yu-Lu Peng, Kang Ning, Ze-Shen Wu...
https://pubmed.ncbi.nlm.nih.gov/34416355Canadian Urological Association guideline on the management of non-muscle-invasive bladder cancer - Full-text.
Bimal Bhindi, Ronald Kool, Girish S Kulkarni...
https://pubmed.ncbi.nlm.nih.gov/33938798