Neobladder Posterior Wall Suspended With Round Ligament of Uterus

Zhiwen Chen76 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

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

Interventions

rONBPROCEDURE

Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Urology Institute of PLA, Southwest Hospital

Chongqing, China

Outcomes

Primary Outcomes

postvoiding residual urine (PVP)

number of patients with postvoiding residual urine (PVP) more than 100ml

Time frame: 2 years after operation

clean intermittent catheterization(CIC)

number of patients required clean intermittent catheterization(CIC)

Time frame: 2 years after operation

Secondary Outcomes

rate of complication

number of patients with any complication

Time frame: through study completion, an average of 2 years

urodynamic profile

urodynamic parameter including peak flow rate, functional urethral length ...etc

Time frame: 12 months afer operation

rate of continence of neobladder

number of patients with continence at daytime and nighttime

Time frame: 12 months after operation

Data from ClinicalTrials.gov

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