RecruitingNot ApplicableNCT05067101

Comparison Capsule Sparing Cystectomy and Radical Cystoprostatectomy in Men with Bladder Cancer

A Randomized Controlled Study to Compare the Oncology Outcome and Functional Recovery of Capsule Sparing Cystectomy and Radical Cystoprostatectomy with Detaenial Sigmoid Neobladder in Men Suffering from Bladder Cancer


Sponsor

Zhujiang Hospital

Enrollment

126 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Bladder cancer is a common malignant tumor of the urinary system, radical resection plus urinary diversion is the first choice of treatment for muscle invasive bladder cancer. Urinary diversion of surgical options related to patient'survival and quality of life. In 2000, professor Chunxiao Liu invented "detaenial sigmoid neobladder", this surgical method overset the traditional intestinal detubularization approach, which detached the serosal layer with smooth muscle from the bowel without split it. This kind of neobladder is easier to construct and have less impact on intestinal function. So far, it has been implemented for more than 700 cases in Zhujiang hospital, the age of patients range from 9 months (bladder rhabdomyosarcoma) to 88 years old. The filed of standard radical bladder cancer resection includes the structure of the prostate and seminal vesicles. More and more studies and long-term clinical experience in our hospital have confirmed that capsule sparing cystectomy can achieve good tumor control and excellent functional recovery. Our project is going to perform a randomized controlled trial for capsule sparing cystectomy and conventional radical cystoprostatectomy and look forward to assess the oncology outcome and functional recovery of these two procedures which provide an objective basis for the patients undergoing orthotopic urinary diversion in the future.


Eligibility

Sex: MALEMin Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study compares two surgical approaches for bladder cancer in men: a standard radical cystoprostatectomy (removing the entire bladder and prostate) versus a "capsule-sparing cystectomy" that removes the bladder but spares the prostate capsule, potentially preserving sexual function and urinary continence. **You may be eligible if...** - You are a male aged 20 or older with bladder cancer (muscle-invasive, carcinoma in situ, high-grade T1, or BCG-unresponsive carcinoma in situ) - Your cancer is clinical stage cT2–T3, without lymph node or distant spread - Your overall health is good (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has invaded the prostate or urethra - You have cancer that has spread to other parts of the body - You have had another cancer within the past 3 years - Your kidneys, heart, or lungs are severely compromised Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECapsule Sparing Cystectomy (CSC)

Adopt endoscopic enucleation technology to preserve the prostate capsule and part of the urinary control support structure to help restore urinary control and erectile functions

PROCEDUREConventional Radical Cystoprostatectomy (CRC)

According to the consensus standard program, remove the accessory tissues including the bladder, prostate and seminal vesicles


Locations(1)

Chunxiao Liu

Guangzhou, Guangdong, China

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NCT05067101


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