Chunxiao Liu
Guangzhou, Guangdong, 510282, China
Location status: Recruiting
Location contact
Chunxiao Liu, doctor
CONTACT
Peng Xu, doctor
CONTACT
NCT Number: NCT05067101
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.
Interested in participating?
Request Info20 year and older
Male
Interventional
Not applicable
Guangzhou, Guangdong, 510282, China
Location status: Recruiting
Chunxiao Liu, doctor
CONTACT
Peng Xu, doctor
CONTACT
CSC group:patients undergoing transurethral resection and enucleation of the prostate first, do not open the bladder neck to maintain the integrity of the bladder neck. The enucleated prostate capsule is preserved under laparoscopic surgery, and the urinary catheter is stretched during the operation to avoid implantation and metastasis.
CRC group:patients undergoing conventional radical cystoprostatectomy. All the patients undergoing detaenial sigmoid neobladder after cystectomy and accept at least 36 months follow up.
Followup: Patients were followed up at every 3-6 mo after surgery in the first 2 yr. The last follow-up was in the 36th month. Biochemical examination、blood and urine routine tests were done every 3 to 12 months. Urodynamic investigation, cystoscopic examination, pelvic computerized tomography, renal dynamic imaging and retro-cystogram were also performed every 3 to 12 months postoperatively.
Postoperative complications were classified as early (90 days or less) and late (greater than 90 days). Early and late complications were subdivided into those related and not related to the neobladder. Complication grade was classified according to the Clavien-Dindo system. Major complications were defined as grade III or higher.
During the follow-up period, patients were asked about daytime and night-time continence and erectile function (EF). Bladder Cancer Index and International Index of Erectile Function-5 (IIEF-5) are designed to evaluate patients' urinary control and sexual function
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
According to the consensus standard program, remove the accessory tissues including the bladder, prostate and seminal vesicles
Time frame: At the 12th month after surgery
Assess post-operative urinary function using the bladder cancer index (BCI) at the 12th month after surgery
Time frame: 36 months
Determine bladder cancer control with CSC compared to CRC as measured by margin status and time to disease recurrence
Time frame: 36 months
Assess post-operative sexual function using IIEF-5 score
Time frame: 24 hour
Including surgical time, bleeding volume, blood transfusion volume, etc.
Time frame: 30 days after surgery
Including intensive care time, time to restore full flow diet, hospitalization time, drainage tube removal time, visual pain score, etc
Time frame: 36 months
Assess rate of serious complications using Clavien Dindo Complication Grading System
Contact information is provided by the study sponsor or research team.
Chunxiao Liu, doctor
CONTACT
Peng Xu, doctor
CONTACT
Zhujiang Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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