Satisfaction of Patients With Trans-Arterial Radial Access: Quality of Life in Uterine Fibroid Embolization Trial

Not Applicable

Completed

• Conditions: Uterine Fibroid
• Interventions: Procedure: Arterial access

• Registration Number: NCT03021720
• Lead Sponsor: Mount Sinai Hospital, Canada

Brief Summary

Randomized trial comparing uterine fibroid embolization patient satisfaction and quality of life with femoral versus radial arterial access

Detailed Description

1:1 randomized trial comparing patient satisfaction and quality of life with femoral versus radial arterial access for uterine fibroid embolization

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-16
• Primary Completion: 2020-02
• Study Completion: 2020-02
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Meeting standard eligibility criteria for uterine fibroid embolization
• Satisfactory ulnopalmar arch patency

Exclusion Criteria

• Unable to provide informed consent
• Unable or unwilling to complete the study questionnaires
• Failed Barbeau test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Femoral arterial access	Arterial access	Femoral arterial puncture for the uterine fibroid embolization procedure
Radial arterial access	Arterial access	Radial arterial puncture for the uterine fibroid embolization procedure

Primary Outcome Measures

Name	Time	Method
Patient satisfaction	From date of procedure to one month after procedure	Based on visual analog scale (min 0, max 10; higher score indicates better outcome)

Secondary Outcome Measures

Name	Time	Method
Procedure time	Duration of intra-procedural time	Procedure time
Fluoroscopy Time	Duration of intra-procedural fluoroscopy	Fluoroscopy time used during the procedure
Procedure equipment cost	Procedure	Cost of disposable equipment used for the procedure
Procedure related complication rate	Up to one month after procedure	Complications categorized based on the Society of Interventional Radiology Standards of Practice Guideline
Health related quality of life	1 month post procedure	Health related quality of life short form-8 questionnaire (raw score converted to standardised score min 0, max 100; higher score indicates better outcome)

Trial Locations

Locations (2)

University Health Network; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada