Comparison of Pain of Two Different Methods in Uterine Artery Embolization

Not Applicable

Completed

• Conditions: Leiomyoma
• Interventions: Device: Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere

• Registration Number: NCT03420248
• Lead Sponsor: Severance Hospital

Brief Summary

The primary purpose of this study is to compare pain after uterine artery embolization using non-spherical polyvinyl alcohol particles 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 non-spherical polyvinyl alcohol particle 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 non-spherical polyvinyl alcohol particles or tris-acryl gelatin microsphere in patients with symptomatic fibroids

Study Timeline

• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-05
• Study Start: 2018-04-19
• Primary Completion: 2019-02-08
• Study Completion: 2019-05-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 54

Inclusion Criteria

• Uterine artery embolization due to multiple fibroids

Exclusion Criteria

• Severe liver or kidney dysfunction
• Drug allergy
• Bradycardia (<45 bpm) or heart block
• Uncontrolled hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-spherical polyvinyl alcohol particle	Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere	For embolic material, non-spherical polyvinyl alcohol particle is used.
Tris-acryl gelatin microsphere	Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere	For embolic material, Tris-acryl gelatin microsphere is used.

Primary Outcome Measures

Name	Time	Method
Pain intensity by numerical rating scale	0-24 h after UAE	0-10 numerical rating scale (0, no pain at all; 10, worst pain imaginable

Secondary Outcome Measures

Name	Time	Method
White blood cell count	24 h after UAE	/uL
Neutrophil-to-lymphocyte ratio	24 h after UAE
Mean platelet volume	24 h after UAE	fL(femtolitre)
Sucessful rate at 3 month after UAE measured by MRI	3 month after UAE	Complete necrosis incidence
Platelet-to-lymphocyte ratio	24 h after UAE
C-reactive protein	24 h after UAE	mg/L
Neutrophil percentage	24 h after UAE

Trial Locations

Locations (1)

Sesverance Hospital, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of