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NCT04966130 Clinical Trial

Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.

Muscle-Invasive Bladder Carcinoma Clinical Trial

Official title:
Effect of Urinary Indwelling Time on Early Continence After Robot-assisted Radical Cystectomy With Orthotopic Ileal Neobladder.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04966130
Other study ID # SysMU-RARC1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date August 31, 2022

Study information
Verified date July 2021
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Hao Chen
Phone +86-02034078960
Email chenh585@mail2.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The clinical trial assesses the effect of urinary indwelling time on early continence after robot- assisted radical cystectomy with orthotopic ileal neobladder.

Description:

Radical cystectomy is the gold standard for muscle-invasive bladder. Orthotopic ileal neobladder, as one of the urinary diversion methods, is preferred whenever possible to achieve a better postoperative quality of life. After surgery, the patient usually indwells a catheter until the anastomotic site heals. And the urinary indwelling time may have an effect on early continence. This is a prospective study including patients undergoing RARC with orthotopic ileal neobladder. Urinary continence recovery and perioperative complication will be analyzed.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 96
Est. completion date August 31, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers
Gender Male
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: 1. Patients with pathologically confirmed bladder cancer 2. Undergoing robot-assisted radical cystectomy with orthotopic ileal neobladder 3. Complete perioperative clinical data Exclusion Criteria: 1. Patients diagnosed with distant metastasis 2. Patients who had urinary incontinence before surgery 3. Patients with unavailable follow-up data

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University First Affiliated Hospital, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University

Outcome
Type Measure Description Time frame Safety issue
Primary Day-time continence rate 1 year
Primary Night-time continence rate 1 year
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