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To develope nerve sparing radical hysterectomy for treatment of cervical cancer to minimize the complication of radical hysterectomy and to maximize quality of life and to evaluate the feasibility and efficacy by prospective randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerve sparing radical hysterectomy group | Experimental |
|
|
| Radical hysterectomy group | Active Comparator | Conventional radical hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve sparing radical hysterectomy | Procedure | Nerve sparing radical hysterectomy
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of bladder dysfunction after surgery | Remove foley catheter and measure the residual urine volume Measure how long it took to be residual urine volume under 50 mL | 5 days after the surgery |
| Measure | Description | Time Frame |
|---|---|---|
| rectal & anal function after surgery | 6, 12 months after surgery | |
| Sexual function | 6, 12 months after surgery | |
| Quality of life |
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Inclusion Criteria:
Exclusion creteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joo-Hyun Nam, M.D., Ph.D. | Contact | 82-2-3010-3633 | jhnam@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Joo-Hyun Nam, M.D., Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center | Recruiting | Seoul | 138-736 | South Korea |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| 6, 12 months after surgery |
| operative time | immediately after surgery |
| amount of bleeding in operation | immediately after surgery |
| frequency of blood transfusion | within 1 week after surgery |
| amount of blood transfusion | within 1 week after surgery |
| postoperative complication | within 1 month after surgery |
| time from surgery to return to work | within 1 month after surgery |
| management cost | within 1 week after surgery |
| size of resected parametrial tissue | immediately after surgery |
| 2year disease free survival | 2 year after treatment |
| D009369 |
| Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |