Text Size

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Southwest Hospital, China
ClinicalTrials.gov Identifier:
NCT01273987
First received: January 7, 2011
Last updated: January 10, 2011
Last verified: December 2010
History of Changes

January 7, 2011
January 10, 2011
December 2010
December 2012   (final data collection date for primary outcome measure)
  • residual urine Change after operation [ Time Frame: 3,6,12,18,24month after operation ] [ Designated as safety issue: Yes ]
  • score of life quality Change after operation [ Time Frame: 3,6,12,18,24 month after operation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01273987 on ClinicalTrials.gov Archive Site
  • information about operation [ Time Frame: discharge from hospital ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • urine control Change after operation [ Time Frame: 3,6,12,18,24 month after operation ] [ Designated as safety issue: Yes ]
    urine controll at daytime;urine controll at nighttime
Same as current
Not Provided
Not Provided
 
Neobladder Posterior Wall Suspended With Round Ligament of Uterus After Radical Cystectomy in Female With Bladder Cancer —a Prospective Control Study
Not Provided

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
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Female
  • Bladder Cancer
  • Radical Cystectomy
  • Neobladder
  • Posterior Wall Suspended With Round Ligament of Uterus
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
Active Comparator: standard neobladder
Intervention: Procedure: Neobladder posterior wall suspended with round ligament of uterus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
70
December 2013
December 2012   (final data collection date for primary outcome measure)

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
Female
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01273987
Neobladder-01
No
Zhiwen Chen, Southwest Hospital, China
Southwest Hospital, China
Not Provided
Study Chair: ZhiWen Chen, Master Urology Institute of Southwest Hospital, Chongqin, China
Principal Investigator: HuiXiang Ji, Doctor Urology Institute of Southwest Hospital, Chongqin, China
Southwest Hospital, China
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP