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Comparison Capsule Sparing Cystectomy and Radical Cystoprostatectomy in Men With Bladder Cancer

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 years later Dec 1, 2025 → Dec 1, 2028
See other at-risk trials from Zhujiang Hospital

Record History

  1. Primary completion pushed from Dec 1, 2025 to Dec 1, 2028 Completion pushed from Dec 1, 2026 to Jul 1, 2029 · Eligibility criteria expanded, about 13 words · Publications: details revised at 12 of 12 entries Show 3 more changesShow less
    • Completion pushed from Dec 1, 2026 to Jul 1, 2029
    • Eligibility criteria expanded, about 13 words
    • Publications: details revised at 12 of 12 entries
  2. Start date changed from estimate of Apr 1, 2024 to Sep 10, 2024v6
  3. Trial status: Not Yet Recruiting to Recruiting Start date: Oct 1, 2023 to Apr 1, 2024 · Site details revisedv5 Show 2 more changesShow less
    • Start date: Oct 1, 2023 to Apr 1, 2024
    • Site details revised
  4. Enrollment target: 56 to 126 Primary completion date: Aug 5, 2023 to Dec 1, 2025 · Start date: Aug 5, 2022 to Oct 1, 2023 · Study sites: 0 to 1 · 5 morev4 Show 8 more changesShow less
    • Primary completion date: Aug 5, 2023 to Dec 1, 2025
    • Start date: Aug 5, 2022 to Oct 1, 2023
    • Study sites: 0 to 1
    • Completion date: Aug 5, 2025 to Dec 1, 2026
    • Interventions: Capsule Sparing Cystectomy (Procedure), Conventional Radical Cystoprostatectomy (Procedure) to Capsule Sparing Cystectomy (CSC) (Procedure), Conventional Radical Cystoprostatectomy (CRC) (Procedure)
    • Eligibility criteria expanded, about 63 words
    • Secondary endpoints: 2 to 5
    • Study description shortened, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  5. Start date: Feb 5, 2022 to Aug 5, 2022v3
  6. Eligibility criteria shortened, about 11 wordsv2 See this version in full on ClinicalTrials.gov ↗
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Zhujiang Hospital
72 trials monitored
See 5 trials at risk
Bladder Cancer
1,022 trials monitored
See 71 trials at risk
Bladder cancer is a common malignant tumor of the urinary system, radical resection plus urinary diversion is the first choice of treatment for muscle invasive bladder cancer. Urinary diversion of surgical options related to patient'survival and quality of life. In 2000, professor Chunxiao Liu invented "detaenial sigmoid neobladder", this surgical method overset the traditional intestinal detubularization approach, which detached the serosal layer with smooth muscle from the bowel without split it. This kind of neobladder is easier to construct and have less impact on intestinal function. So far, it has been implemented for more than 700 cases in Zhujiang hospital, the age of patients range from 9 months (bladder rhabdomyosarcoma) to 88 years old. The filed of standard radical bladder cancer resection includes the structure of the prostate and seminal vesicles. More and more studies and long-term clinical experience in our hospital have confirmed that capsule sparing cystectomy can achieve good tumor control and excellent functional recovery. Our project is going to perform a randomized controlled trial for capsule sparing cystectomy and conventional radical cystoprostatectomy and look forward to assess the oncology outcome and functional recovery of these two procedures which provide an objective basis for the patients undergoing orthotopic urinary diversion in the future.
Trial Details
NCT Number NCT05067101
Lead Sponsor Zhujiang Hospital
Conditions Bladder Cancer
Enrollment 126 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov