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| Name | Class |
|---|---|
| Tumor Hospital of Xin Jiang Medical University,China | UNKNOWN |
| Gui Yang Maternal and Child Health Hospital,China | UNKNOWN |
| 152nd Hospital of Chinese People's Liberation Army | OTHER |
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The investigators designed this multicentre randomized study to investigate the clinical benefits of nerve-spring radical hysterectomy for cervical cancer. Patients with FIGO stage Ia2, Ib1, IIa1 and FIGO stage Ib2, IIa2 after neoadjuvant chemotherapy are randomized to either nerve-spring radical hysterectomy or radical hysterectomy. The primary endpoint are urodynamic outcome including maximum flow rate, residual volume, maximum vesical compliace, cystomctric capacity at first desire, and maximum cystomctric capacity. A total 240 patients (120 per treatment arm) are planned to accrue for this study within 7 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NSRH | Experimental | patients in Arm NSRH undergo nerve-spring radical hysterectomy (NSRH) |
|
| RH | Active Comparator | patients in Arm RH undergo radical hysterectomy (RH) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerve-spring radical hysterectomy | Procedure | Nerve-spring radical hysterectomy that is reserve some pelvic autonomic nerves during radical hysterectomy. Reserve hypogastric nerve trunk during dissecting cardinal ligament. Reserve pelvic splanchnic nerve trunk during exsecting uterosacral ligament. Reserve bladder nerve of pelvic plexus during dissecting vesicouterine ligament. |
| Measure | Description | Time Frame |
|---|---|---|
| maximum flow rate measured by Urodynamic at 6 months postoperative | on 6 months postoperative | |
| residual volume measured by Urodynamic at 6 months postoperative | on 6 months postoperative | |
| maximum vesical compliace measured by Urodynamic at 6 months postoperative | on 6 months postoperative | |
| cystometric capacity at first desire measured by Urodynamic at 6 months postoperative | on 6 months postoperative | |
| maximum cystometric capacity (MCC) measured by Urodynamic at 6 months postoperative | on 6 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Time (days) to residual urine volume less than 100ml postoperative | from operation to residual urine volume less than 100ml, assessed up to 30 days | |
| time (hours) to break wind postoperative | from operation to have the first break wind, assessed up to 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenlin Chen, M.D.,Ph.D. | Contact | +8602062787947 | chenchunlinrct@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Medical University, China | Guangzhou | Guangdong | 510515 | China |
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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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|
| radical hysterectomy | Procedure | Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy. |
|
| time (hours) to defecation postoperative | from operation to have the first defection, assessed up to 72 hours |
| Number of participants with adverse events | From date of operation until the date of first documented adverse event or date of death from any cause, whichever came first, assessed up to 5 years |
| Score of MHU rating scales at 6 months postoperative | on 6 months postoperative |
| overall survival | From date of operation until the date of death from any cause, assessed up to 5 years |
| progression-free survival | From date of operation until the date of relapse or date of death from any cause, whichever came first, assessed up to 5 years |
| Score of C-30 life quality rating scales at 6 months postoperative | on 6 months postoperative |
| Score of CX-24 life quality rating scales at 6 months postoperative | on 6 months postoperative |
| 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 |