Back to resultsNeobladder Posterior Wall Suspended With Round Ligament of Uterus
Primary Purpose
Female, Bladder Cancer, Radical Cystectomy
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rONB
Sponsored by
About this trial
This is an interventional treatment trial for Female
Eligibility 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
Sites / Locations
- Urology Institute of PLA, Southwest Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
neobladder with round lig
standard neobladder
Arm Description
ileal neobladder suspened with round ligament
conventional standard neobladder
Outcomes
Primary Outcome Measures
postvoiding residual urine (PVP)
number of patients with postvoiding residual urine (PVP) more than 100ml
clean intermittent catheterization(CIC)
number of patients required clean intermittent catheterization(CIC)
Secondary Outcome Measures
rate of complication
number of patients with any complication
urodynamic profile
urodynamic parameter including peak flow rate, functional urethral length ...etc
rate of continence of neobladder
number of patients with continence at daytime and nighttime
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01273987
Brief Title
Neobladder Posterior Wall Suspended With Round Ligament of Uterus
Official Title
Neobladder Posterior Wall Suspended With Round Ligament of Uterus After Radical Cystectomy in Female With Bladder Cancer -a Prospective Control Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2011 (Actual)
Primary Completion Date
November 8, 2019 (Actual)
Study Completion Date
March 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zhiwen Chen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
Detailed Description
The investigators developed a technical modification which to aim to provide an posterior support to the ideal neobladder and obtain the anatomy recovered neobladder by posterior wall of neobladder suspended with round ligament. In this study the investigators designed the prospective random trial to evaluate whether this technique improves the neobladder empty compared to a current standard neobladder reconstruction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female, Bladder Cancer, Radical Cystectomy, Neobladder, Posterior Wall Suspended With Round Ligament of Uterus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
neobladder with round lig
Arm Type
Experimental
Arm Description
ileal neobladder suspened with round ligament
Arm Title
standard neobladder
Arm Type
No Intervention
Arm Description
conventional standard neobladder
Intervention Type
Procedure
Intervention Name(s)
rONB
Intervention Description
Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer
Primary Outcome Measure Information:
Title
postvoiding residual urine (PVP)
Description
number of patients with postvoiding residual urine (PVP) more than 100ml
Time Frame
2 years after operation
Title
clean intermittent catheterization(CIC)
Description
number of patients required clean intermittent catheterization(CIC)
Time Frame
2 years after operation
Secondary Outcome Measure Information:
Title
rate of complication
Description
number of patients with any complication
Time Frame
through study completion, an average of 2 years
Title
urodynamic profile
Description
urodynamic parameter including peak flow rate, functional urethral length ...etc
Time Frame
12 months afer operation
Title
rate of continence of neobladder
Description
number of patients with continence at daytime and nighttime
Time Frame
12 months after operation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZhiWen Chen, M.D.
Organizational Affiliation
Urology Institute of PLA, Southwest Hospital, Chongqin, China
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
HuiXiang Ji, M.D.
Organizational Affiliation
Urology Institute of PLA, Southwest Hospital, Chongqin, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Urology Institute of PLA, Southwest Hospital
City
Chongqing
ZIP/Postal Code
400038
Country
China
12. IPD Sharing Statement
Learn more about this trial
Neobladder Posterior Wall Suspended With Round Ligament of Uterus
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