Spherical Gelfoam Versus Tri-acryl Microsphere for Uterine Artery Embolization for Symptomatic Fibroids

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Comparison of Pain After Uterine Artery Embolization Using Spherical Gelfoam or Tris-acryl Gelatin Microsphere in Patients With Symptomatic Fibroids: A Prospective, Randomized Study

Conditions
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Symptomatic Uterine Fibroids

Intervention / Treatment
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* Procedure: uterine artery embolization using spherical gelfoam
* Procedure: uterine artery embolization using tri-acryl gelatin microsphere


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Women with symptomatic fibroids (age: 20 - 60 years old) Exclusion Criteria: Bradycardia (<45 bpm) Conduction abnormalities Liver failure renal failure Uncontrolled hypertension High grade obesity (BMI ≥ 30 kg/m2) Drug allergy Illiteracy Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spherical gelfoam<br>Patients who receive uterine artery embolization for symptomatic fibroids | Procedure: uterine artery embolization using spherical gelfoam<br>* Uterine artery embolization is performed using spherical gelfoam. All other processes are same.<br>|
| Active Comparator: Microsphere<br>Patients who receive uterine artery embolization for symptomatic fibroids | Procedure: uterine artery embolization using tri-acryl gelatin microsphere<br>* Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score (VAS score) | Maximum pain score measured during 24 hours after embolization | up to 24 hours after embolization | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibroid, Embolization, Pain, Inflammation