Neobladder Posterior Wall Suspended With Round Ligament of Uterus

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Female, Bladder Cancer, Radical Cystectomy, Neobladder, Posterior Wall Suspended With Round Ligament of Uterus

Intervention / Treatment
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* Procedure: rONB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: neobladder with round lig<br>ileal neobladder suspened with round ligament | Procedure: rONB<br>* Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer<br>|
| No Intervention: standard neobladder<br>conventional standard neobladder | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postvoiding residual urine (PVP) | number of patients with postvoiding residual urine (PVP) more than 100ml | 2 years after operation | 
| clean intermittent catheterization(CIC) | number of patients required clean intermittent catheterization(CIC) | 2 years after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of complication | number of patients with any complication | through study completion, an average of 2 years | 
| urodynamic profile | urodynamic parameter including peak flow rate, functional urethral length ...etc | 12 months afer operation | 
| rate of continence of neobladder | number of patients with continence at daytime and nighttime | 12 months after operation |