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The primary purpose of this study is to compare pain after uterine artery embolization using spherical gelfoam or tris-acryl gelatin microsphere in patients with symptomatic fibroids
Uterine artery embolization(UAE) is a minimally invasive treatment alternative to hysterectomy and myomectomy in symptomatic fibroids. However, post-procedural pain after UAE remains a major problem. The spherical gelfoam and tri-acryl gelatin microsphere are two embolic materials used for UAE. Therefore, the aim of study is to compare pain intensity and inflammation after uterine artery embolization using the two embolic agents with symptomatic fibroids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spherical gelfoam | Experimental | Patients who receive uterine artery embolization for symptomatic fibroids |
|
| Microsphere | Active Comparator | Patients who receive uterine artery embolization for symptomatic fibroids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| uterine artery embolization using spherical gelfoam | Procedure | Uterine artery embolization is performed using spherical gelfoam. All other processes are same. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score (VAS score) | Maximum pain score measured during 24 hours after embolization | up to 24 hours after embolization |
| Measure | Description | Time Frame |
|---|---|---|
| C-reactive protein (mg/L) | inflammatory markers | the day before and 24 hours after embolization |
| Tumor necrosis rate after embolization | technical success indicator |
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Inclusion Criteria:
1. Women with symptomatic fibroids (age: 20 - 60 years old)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Man-Deuk Kim | Contact | 82-10-8625-2197 | mdkim@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Man-Deuk Kim | Department of Radiology, Severance hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University Health System | Seoul | South Korea |
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| uterine artery embolization using tri-acryl gelatin microsphere | Procedure | Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same. |
|
| 1 day and 3 months after embolization |
| Symptom severity questionnaire | clinical success indicator | before and 3 months after embolization |
| White blood cell count (/µL) | inflammatory markers | the day before and 24 hours after embolization |
| Neutrophil percentage (%) | inflammatory markers | the day before and 24 hours after embolization |
| Cumulative fentanyl dose (µg) | Total amount of IV fentanyl administered | within 24 hours after embolization |
| Use of rescue analgesics (%) | Necessity of additional rescue analgesics | within 24 hours after embolization |
| Lymphocyte percentage (%) | Inflammatory marker | the day before and 24 hours after embolization |
| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D010146 | Pain |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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