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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Male
Minimum Age: 20
Healthy Volunteers: f
View:

• Adult males aged 20 and above and healthy volunteers are not accepted;

• Bladder carcinoma in situ、T1G3 tumor、muscle invasive bladder cancer with clinical stage of cT2-T3N0M0 (If the clinical staging before neoadjuvant therapy meets the inclusion criteria, patients who have decreased to below cT2 after neoadjuvant therapy can also choose to be included according to the patient's wishes).

• Recurrent bladder cancer: recurrent NMIBC after treatment and Carcinoma in situ that does not respond to BCG vaccine treatment.

• ECOG score is 0 or 1.

• Voluntarily signed the informed consent.

Locations
Other Locations
China
Chunxiao Liu
RECRUITING
Guangzhou
Contact Information
Primary
Chunxiao Liu, doctor
liuchx888@163.com
+86 13302296795
Backup
Peng Xu, doctor
yihuixp88@hotmail.com
+86 18665073650
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 126
Treatments
Experimental: Capsule Sparing Cystectomy
Patients undergoing transurethral resection and enucleation of the prostate before laparoscopic cystectomy
Placebo_comparator: Conventional Radical Cystoprostatectomy
Patients undergoing conventional radical cystoprostatectomy
Authors
Sponsors
Leads: Zhujiang Hospital

This content was sourced from clinicaltrials.gov