To compare the urinary continence rate and long-term oncological outcomes of pelvic-organ preserving radical cystectomy (POPRC) with orthotopic ileal neobladder (OIN) versus standard radical cystectomy(SRC) with OIN.
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. For standard radical cystectomy (SRC) in females, the uterus, fallopian tubes, ovaries, anterior vaginal wall, and regional lymph nodes undergo en bloc resection with the bladder and urethra . With regard to the wide range of resection, continence disorder and sexual dysfunction are very common after surgery. Pelvic-organ sparing radical cystectomy involves the preservation of the female vagina, uterus, neurovascular bundles, and any enhancement of the aforementioned techniques . Previous studies demonstrated that POPRC might not affect long-term survival and instead improve continence outcomes. However, most of the available studies are retrospective with limited cases in a single center. The current study primarily aims to urinary continence rate and long-term oncological outcomes of POPRC+OIN versus SRC+OIN in a prospective randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, China
day-time and night-time continence rate
We will use pad-test to evaluate the urinary continence for patients
Time frame: 6 months
postoperative sexual function
International index of erectile function-5 (IIEF-5)
Time frame: 6 months
perioperative complications rate
perioperative complications rate within 1 month
Time frame: 1 months
overall survival
5-year overall survival rate
Time frame: 5 years
recurrence-free survival
5-year overall recurrence-free survival rate
Time frame: 5 years
operative time
operative time (mins)
Time frame: 24 hours
estimated blood loss
estimated blood loss (ml)
Time frame: 24 hours
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