Neobladder Posterior Wall Suspended With Round Ligament of Uterus

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

Full Title of Study: “Neobladder Posterior Wall Suspended With Round Ligament of Uterus After Radical Cystectomy in Female With Bladder Cancer -a Prospective Control Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: November 8, 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: neobladder with round lig
    • ileal neobladder suspened with round ligament
  • No Intervention: standard neobladder
    • conventional standard neobladder

Clinical Trial Outcome Measures

Primary Measures

  • postvoiding residual urine (PVP)
    • Time Frame: 2 years after operation
    • number of patients with postvoiding residual urine (PVP) more than 100ml
  • clean intermittent catheterization(CIC)
    • Time Frame: 2 years after operation
    • number of patients required clean intermittent catheterization(CIC)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 40 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zhiwen Chen
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Zhiwen Chen, Vice director of urological institiute of PLA – Southwest Hospital, China
  • Overall Official(s)
    • ZhiWen Chen, M.D., Study Chair, Urology Institute of PLA, Southwest Hospital, Chongqin, China
    • HuiXiang Ji, M.D., Principal Investigator, Urology Institute of PLA, Southwest Hospital, Chongqin, China

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