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Comparison of Safety and Efficacy of Detaenial Sigmoid Neobladder and Ileal Neobladder

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Aug 30, 2025 → Aug 30, 2027
See other at-risk trials from Zhujiang Hospital

Record History

  1. Notable Primary completion pushed from Aug 30, 2025 to Aug 30, 2027 Trial status changed: Unknown → Recruiting · Completion pushed from Sep 30, 2025 to Sep 30, 2028 · Eligibility criteria expanded, about 11 words · 1 more Show 4 more changesShow less
    • Trial status changed: Unknown → Recruiting
    • Completion pushed from Sep 30, 2025 to Sep 30, 2028
    • Eligibility criteria expanded, about 11 words
    • Publications: details revised at 11 of 12 entries
  2. Minor Changed Registry marked status Unknown; last known: Recruiting
  3. Minor Trial status: Recruiting to Unknown Collaborators revised (4)v9 Show 1 more changeShow less
  4. Notable Primary completion date: Aug 30, 2022 to Aug 30, 2025v8
  5. Minor Completion date: Sep 30, 2022 to Sep 30, 2025 Collaborators: 3 to 4v7 Show 1 more changeShow less
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Primary completion date: May 2, 2021 to Aug 30, 2022v6
  2. Notable Primary completion date: May 6, 2020 to May 2, 2021 Start date: May 1, 2017 to May 2, 2018 · Trial status: Enrolling by Invitation to Recruiting · Completion date: Sep 30, 2021 to Sep 30, 2022 · 1 morev5 Show 4 more changesShow less
    • Start date: May 1, 2017 to May 2, 2018
    • Trial status: Enrolling by Invitation to Recruiting
    • Completion date: Sep 30, 2021 to Sep 30, 2022
    • Site details revised
  3. Minor Primary completion date: Jul 1, 2020 to May 6, 2020v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Primary completion date: May 1, 2017 to Jul 1, 2020 Start date: Oct 1, 2016 to May 1, 2017 · Study sites: 0 to 1 · Completion date: Sep 2021 to Sep 30, 2021 · 2 morev2 Show 5 more changesShow less
    • Start date: Oct 1, 2016 to May 1, 2017
    • Study sites: 0 to 1
    • Completion date: Sep 2021 to Sep 30, 2021
    • Secondary endpoints revised (3)
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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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 1988, Hautmann firstly reported an orthotopic urinary diversion method: Hautmann neobladder. As the urine can be controlled from the original urethra, the patient's quality of life has been greatly improved, so the new bladder surgery gradually accepted and welcomed by urologists and patients. However, in order to achieve low-pressure and large-volume storage capacity of the urine reservoir, the 40-70cm long interception of terminal ileum need to be detubularized. Only after split, folded, re-stitched and a series of treatment, the intestinal can be used. Such complicated procedures make so many urologists give it up. In addition, the interception of the long ileum may lead to reduced absorption of vitamin B12 which caused anemia, metabolic acidosis, intestinal dysfunction. Not only that, as time goes by, this kind of neobladder will be unlimited expansion and resulting in a serious increase in residual urine volume, hydronephrosis, or even the occurrence of neobladder spontaneous rupture. 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 600 cases in Zhujiang hospital, the age of patients range from 9 months (bladder rhabdomyosarcoma) to 84 years old. So far as now, no multicenter prospective clinical study on orthotopic urinary diversion has been performed worldwide, neither the head-to-head studies on detaenial sigmoid neobladder and ileal neobladder. Our project is going to perform a multicenter randomized controlled trial for these two neobladder methods and look forward to assess the safety and efficacy of these two procedures which provide an objective basis for the patients undergoing orthotopic urinary diversion in the future.
Trial Details
NCT Number NCT03108196
Lead Sponsor Zhujiang Hospital
Collaborators: Sun Yat-Sen University Cancer Center, The Third Affiliated Hospital of Southern Medical University, Fourth Affiliated Hospital of Guangxi Medical University, Ludwig-Maximilians - University of Munich
Conditions Bladder Cancer, Urinary Diversion
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov