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

Not Applicable

• Conditions: Symptomatic Uterine Fibroids
• Interventions: Procedure: uterine artery embolization using spherical gelfoam; Procedure: uterine artery embolization using tri-acryl gelatin microsphere

• Registration Number: NCT04960293
• Lead Sponsor: Yonsei University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-06-23
• Status Verified: 2021-07
• Study Start: 2021-07
• Study First Submitted QC: 2021-07-11
• Last Update Submitted: 2021-07-11
• Study First Posted: 2021-07-13
• Last Update Posted: 2021-07-13
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Women with symptomatic fibroids (age: 20 - 60 years old)

Exclusion Criteria

1. Bradycardia (<45 bpm)
2. Conduction abnormalities
3. Liver failure
4. renal failure
5. Uncontrolled hypertension
6. High grade obesity (BMI ≥ 30 kg/m2)
7. Drug allergy
8. Illiteracy
9. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spherical gelfoam	uterine artery embolization using spherical gelfoam	Patients who receive uterine artery embolization for symptomatic fibroids
Microsphere	uterine artery embolization using tri-acryl gelatin microsphere	Patients who receive uterine artery embolization for symptomatic fibroids

Primary Outcome Measures

Name	Time	Method
Pain score (VAS score)	up to 24 hours after embolization	Maximum pain score measured during 24 hours after embolization

Secondary Outcome Measures

Name	Time	Method
C-reactive protein (mg/L)	the day before and 24 hours after embolization	inflammatory markers
Lymphocyte percentage (%)	the day before and 24 hours after embolization	Inflammatory marker
Tumor necrosis rate after embolization	1 day and 3 months after embolization	technical success indicator
Symptom severity questionnaire	before and 3 months after embolization	clinical success indicator
Cumulative fentanyl dose (µg)	within 24 hours after embolization	Total amount of IV fentanyl administered
Use of rescue analgesics (%)	within 24 hours after embolization	Necessity of additional rescue analgesics
Neutrophil percentage (%)	the day before and 24 hours after embolization	inflammatory markers
White blood cell count (/µL)	the day before and 24 hours after embolization	inflammatory markers

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of