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Evaluation of the clinical efficacy of intraoperative urethral irrigation for preventing urethral recurrence after radical cystectomy

Evaluation of the clinical efficacy of intraoperative urethral irrigation for preventing urethral recurrence after radical cystectomy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040539
Enrollment
Unknown
Registered
2020-12-01
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer

Interventions

non-urethral irrigation:None
Distilled water urethral irrigation group:Distilled water urethral irrigation
Low-dose pirarubicin urethral irrigation group:Pirubicin

Sponsors

Changhai Hospital, Yangpu District, Shanghai
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The patient is over 18 years old; 2. Before the operation, it was confirmed as bladder urothelial carcinoma by cystoscopy and pathological biopsy, and cystoscopy and imaging examinations excluded tumors infiltrating the urethra or multiple tumors of the urethra; 3. Urinary diversion after radical cystectomy is ureteral skin stoma, ileum replacement bladder or in-situ neobladder; 4. Sign the informed consent form for entry into the clinical trial.

Exclusion criteria

Exclusion criteria: 1. Preoperative cystoscopy biopsy confirmed non-urothelial carcinomas such as squamous cell carcinoma and bladder adenocarcinoma; 2. Unable to understand the research process and unwilling to follow up after the operation; 3. Past history of urothelial cancer; 4. There is distant transfer; 5. Combined with urethral tumors; 6. Merge other malignant tumors; 7. Receive neoadjuvant chemotherapy before surgery; 8. Receive systemic chemotherapy and radiotherapy after surgery; 9. Combined with heart, liver, kidney and other organ dysfunction.

Design outcomes

Primary

MeasureTime frame
Urethral recurrence rate;

Secondary

MeasureTime frame
Disease-specific survival;Recurrence-free survival;

Countries

China

Contacts

Public ContactZhang Zhensheng

Department of Urology, Changhai Hospital, Yangpu District

13761178177@163.com+86 13761178177

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026