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The efficacy and safety of uterine artery embolization, as compared with standard surgical methods, for the treatment of symptomatic uterine fibroids remain uncertain. The purpose of this trial is to evaluate the uterine volume and tumor size reduction, symptomatic relief, complication, fertility, ovarian function and quality of life with uterine artery embolization for uterine fibroids comparing with standard surgical methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pregnancy expectation | Active Comparator | The patients who desire for future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group. |
|
| No pregnancy expectation | Active Comparator | The patients who don't desire for reserving uterus and/ or future pregnancy will enroll into this arm , and will be divided into UAE group and SURGERY group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventional radiological or surgical management | Procedure | Uterine artery embolization will be done for the patients who enroll into UAE group and desire for future pregancy and reserving uterus.Myomectomy will be performed for the patients who enroll into SURGERY group and desire for future pregancy and reserving uterus.Hysterectomy will be done for the patients who enroll into SURGERY group and don't desire for reserving uterus and/or future pregnancy. |
| Measure | Description | Time Frame |
|---|---|---|
| quality of life | 1,3,5,10 year. | |
| pregnant | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| tumor recurrence | 1,3,5,10 years | |
| complications | 3,6,12,24 months | |
| ovarian functions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hong Shan, M.D., PHD. | Third Affiliated Hospital, Sun Yat-Sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital of Nanfang medical University | Guangzhou | Guangdong | 510000 | China | ||
| Guangdong Provincial People's Hospital |
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| Label | URL |
|---|---|
| The Third Affiliated Hospital of Sun Yat-sen University | View source |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| 3,6,12 months, 2,3,5 and 10 years |
| symptom relief | 3,6,12,24 months |
| tumour volume | 3,6,12 18 24 months and 3,5,10 years |
| Guangzhou |
| Guangdong |
| 510080 |
| China |
| the first Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510089 | China |
| Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |