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Neobladder Posterior Wall Suspended With Round Ligament of Uterus After Radical Cystectomy in Female With Bladder Cancer —a Prospective Control Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Southwest Hospital, China.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01273987
First Posted: January 11, 2011
Last Update Posted: January 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Southwest Hospital, China
  Purpose
Objective: to evaluate if the Neobladder posterior wall suspended with round ligament of uterus could improve neobladder empty after radical cystectomy in female patients with bladder cancer compared to present standard neobladder

Condition Intervention Phase
Female Bladder Cancer Radical Cystectomy Neobladder Posterior Wall Suspended With Round Ligament of Uterus Procedure: Neobladder posterior wall suspended with round ligament of uterus Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Southwest Hospital, China:

Primary Outcome Measures:
  • residual urine Change after operation [ Time Frame: 3,6,12,18,24month after operation ]
  • score of life quality Change after operation [ Time Frame: 3,6,12,18,24 month after operation ]

Secondary Outcome Measures:
  • information about operation [ Time Frame: discharge from hospital ]
    hemorrhage; blood transfusion; persistence time of operation; Length of Stay after operation

  • urodynamic parameter Change after operation [ Time Frame: 3,6,12,18,24 month afer operation ]
  • urine control Change after operation [ Time Frame: 3,6,12,18,24 month after operation ]
    urine controll at daytime;urine controll at nighttime


Estimated Enrollment: 70
Study Start Date: December 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: standard neobladder Procedure: Neobladder posterior wall suspended with round ligament of uterus
Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The inclusion criteria for the study were bladder cancer (Stage T1G3, T2-3N0-NxM0), female (age between 40 and 70 years old), no history of urethral trauma or urethral stricture; and a desire to obtain an orthotopic neobladder

Exclusion Criteria:

  • The exclusion criteria were male sex, posterior urethral margin confirmed as cancer invasive by pathology; and enteritis. The indications and contraindications for orthotopic reconstruction in this study conformed to the criteria set by the guidelines of the European Association of Urology on bladder cancer
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01273987


Locations
China, ChongQin
Urology Institute of Southwest Hospital
Shapinba, ChongQin, China, 400038
Sponsors and Collaborators
Southwest Hospital, China
Investigators
Study Chair: ZhiWen Chen, Master Urology Institute of Southwest Hospital, Chongqin, China
Principal Investigator: HuiXiang Ji, Doctor Urology Institute of Southwest Hospital, Chongqin, China
  More Information

Responsible Party: Zhiwen Chen, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT01273987     History of Changes
Other Study ID Numbers: Neobladder-01
First Submitted: January 7, 2011
First Posted: January 11, 2011
Last Update Posted: January 11, 2011
Last Verified: December 2010

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases