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

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

      • Chongqing, China, 400038
        • Urology Institute of PLA, Southwest Hospital

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
Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer
No Intervention: standard neobladder
conventional standard neobladder

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
2 years after operation
clean intermittent catheterization(CIC)
Time Frame: 2 years after operation
number of patients required clean intermittent catheterization(CIC)
2 years after operation

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
through study completion, an average of 2 years
urodynamic profile
Time Frame: 12 months afer operation
urodynamic parameter including peak flow rate, functional urethral length ...etc
12 months afer operation
rate of continence of neobladder
Time Frame: 12 months after operation
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

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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