Clinical trial NCT05067101: Comparison Capsule Sparing Cystectomy and Radical Cystoprostatectomy in Men with Bladder Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bladder Cancer
Keywords: bladder cancer
detaenial sigmoid neobladder
prostate capsule sparing
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 126
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Preoperative serum creatinine more than 2.26mg/dl Or 200μmol/L.
* Cancer invaded prostate or urethral (confirmed by the pathology).
* Patients with distant metastasis.
* Abnormal PSA level, or suspected patients with unconfirmed prostate cancer .
* A history of other malignant tumors within three years.
* sigmoid chronic inflammation, like ulcerative colitis or intestinal tuberculosis, and so on.
* Severe cardiopulmonary and liver dysfunction, combined with other serious diseases
* Other conditions that have been approved by a urologist for not suitable for neobladder surgery.

Primary outcomes:
measure: Post-operative urinary function
timeFrame: At the 12th month after surgery
Secondary outcomes:
measure: bladder cancer specific survival rate
timeFrame: 36 months
measure: Sexual function
timeFrame: 36 months
measure: Intraoperative conditions
timeFrame: 24 hour
measure: Early postoperative rehabilitation indicators
timeFrame: 30 days after surgery
measure: Rate of serious complications
timeFrame: 36 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Chunxiao Liu
state: Guangdong
Study officials:
affiliation: Southern Medical University, China
name: Chunxiao Liu, doctor
role: PRINCIPAL_INVESTIGATOR
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