Back to resultsDifferences in Quality of Life After Thoracic Outlet Syndrome Surgery
Primary Purpose
Thoracic Outlet Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
QuickDASH form
Sponsored by
About this trial
This is an interventional supportive care trial for Thoracic Outlet Syndrome
Eligibility Criteria
Inclusion Criteria:
- thoracic outel syndrome surgery scheduled in the vascular and thoracic surgery department of Angers ; age > 18 y ; french language understood
Exclusion Criteria:
- denied of consent
Sites / Locations
- University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with a completed form
Arm Description
Outcomes
Primary Outcome Measures
Change from QuickDASH form results before surgery at 6 weeks after surgery
Secondary Outcome Measures
Change from SF-36 form results before surgery at 6 weeks after surgery
Full Information
NCT ID
NCT05426473
First Posted
June 10, 2022
Last Updated
December 8, 2022
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT05426473
Brief Title
Differences in Quality of Life After Thoracic Outlet Syndrome Surgery
Official Title
Differences in Quality of Life After Thoracic Outlet Syndrome Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2022 (Actual)
Primary Completion Date
March 14, 2025 (Anticipated)
Study Completion Date
August 17, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Quality of life evaluation after thoracic outlet surgery with Quick-DASH and SF-36 forms
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Outlet Syndrome
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
112 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with a completed form
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
QuickDASH form
Other Intervention Name(s)
SF-36 form
Intervention Description
Patients have to complete these two forms, Quick DASH and SF-36, before surgery then 6 weeks after
Primary Outcome Measure Information:
Title
Change from QuickDASH form results before surgery at 6 weeks after surgery
Time Frame
Results before surgery and at 6 weeks after surgery are compared
Secondary Outcome Measure Information:
Title
Change from SF-36 form results before surgery at 6 weeks after surgery
Time Frame
Results before surgery and at 6 weeks after surgery are compared
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
thoracic outel syndrome surgery scheduled in the vascular and thoracic surgery department of Angers ; age > 18 y ; french language understood
Exclusion Criteria:
denied of consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eva Deveze, Dr
Phone
0686450820
Email
Eva.Deveze@chu-angers.fr
Facility Information:
Facility Name
University Hospital
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Deveze, Dr
Phone
0686450820
Email
Eva.Deveze@chu-angers.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Differences in Quality of Life After Thoracic Outlet Syndrome Surgery
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