- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01273987
Neobladder Posterior Wall Suspended With Round Ligament of Uterus
March 27, 2020 updated by: Zhiwen Chen
Neobladder Posterior Wall Suspended With Round Ligament of Uterus After Radical Cystectomy in Female With Bladder Cancer -a Prospective Control Study
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
76
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Chongqing, China, 400038
- Urology Institute of PLA, Southwest Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: neobladder with round lig
ileal neobladder suspened with round ligament
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Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer
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No Intervention: standard neobladder
conventional standard neobladder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
postvoiding residual urine (PVP)
Time Frame: 2 years after operation
|
number of patients with postvoiding residual urine (PVP) more than 100ml
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2 years after operation
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clean intermittent catheterization(CIC)
Time Frame: 2 years after operation
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number of patients required clean intermittent catheterization(CIC)
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2 years after operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
rate of complication
Time Frame: through study completion, an average of 2 years
|
number of patients with any complication
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through study completion, an average of 2 years
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urodynamic profile
Time Frame: 12 months afer operation
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urodynamic parameter including peak flow rate, functional urethral length ...etc
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12 months afer operation
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rate of continence of neobladder
Time Frame: 12 months after operation
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number of patients with continence at daytime and nighttime
|
12 months after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: ZhiWen Chen, M.D., Urology Institute of PLA, Southwest Hospital, Chongqin, China
- Principal Investigator: HuiXiang Ji, M.D., Urology Institute of PLA, Southwest Hospital, Chongqin, China
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2011
Primary Completion (Actual)
November 8, 2019
Study Completion (Actual)
March 20, 2020
Study Registration Dates
First Submitted
January 7, 2011
First Submitted That Met QC Criteria
January 10, 2011
First Posted (Estimate)
January 11, 2011
Study Record Updates
Last Update Posted (Actual)
March 31, 2020
Last Update Submitted That Met QC Criteria
March 27, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neobladder-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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