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Neobladder Posterior Wall Suspended With Round Ligament of Uterus

Z

Zhiwen Chen

Status

Completed

Conditions

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

Treatments

Procedure: rONB

Study type

Interventional

Funder types

Other

Identifiers

NCT01273987
Neobladder-01

Details and patient eligibility

About

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 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.

Enrollment

76 patients

Sex

Female

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

76 participants in 2 patient groups

neobladder with round lig
Experimental group
Description:
ileal neobladder suspened with round ligament
Treatment:
Procedure: rONB
standard neobladder
No Intervention group
Description:
conventional standard neobladder

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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