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

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

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

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

Conditions
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Uterine Fibroid

Intervention / Treatment
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* Procedure: Arterial access


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Femoral arterial access<br>Femoral arterial puncture for the uterine fibroid embolization procedure | Procedure: Arterial access<br>* Location of arterial puncture<br>|
| Experimental: Radial arterial access<br>Radial arterial puncture for the uterine fibroid embolization procedure | Procedure: Arterial access<br>* Location of arterial puncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Based on visual analog scale (min 0, max 10; higher score indicates better outcome) | From date of procedure to one month after procedure | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Uterine fibroid embolization, Uterine artery embolization, Arterial access, Radial access, Interventional radiology, Quality of life, Patient Satisfaction, Patient centered care, Uterine fibroid