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| Name | Class |
|---|---|
| Peking University Third Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POPRC group | Experimental | pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder |
|
| SRC group | Active Comparator | standard radical cystectomy with orthotopic ileal neobladder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POPRC+OIN | Procedure | Pelvic-organ preserving radical cystectomy with orthotopic ileal neobladder |
|
| Measure | Description | Time Frame |
|---|---|---|
| day-time and night-time continence rate | We will use pad-test to evaluate the urinary continence for patients | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative sexual function | International index of erectile function-5 (IIEF-5) | 6 months |
| perioperative complications rate | perioperative complications rate within 1 month |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenlong Zhong, MD | Contact | 86-18510904167 | zhongwlong3@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen Memorial Hospital | Guangzhou | Guangdong | China |
IPD will be public access via the ResMan
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D012735 | Sexual Dysfunction, Physiological |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| SRC+OIN | Procedure | Standard radical cystectomy with orthotopic ileal neobladder |
|
| 1 months |
| overall survival | 5-year overall survival rate | 5 years |
| recurrence-free survival | 5-year overall recurrence-free survival rate | 5 years |
| operative time | operative time (mins) | 24 hours |
| estimated blood loss | estimated blood loss (ml) | 24 hours |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D000091662 | Genital Diseases |
| D014555 | Urination Disorders |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |