- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05426473
Differences in Quality of Life After Thoracic Outlet Syndrome Surgery
December 8, 2022 updated by: University Hospital, Angers
Quality of life evaluation after thoracic outlet surgery with Quick-DASH and SF-36 forms
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
112
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Eva Deveze, Dr
- Phone Number: 0686450820
- Email: Eva.Deveze@chu-angers.fr
Study Locations
-
-
-
Angers, France
- Recruiting
- University Hospital
-
Contact:
- Eva Deveze, Dr
- Phone Number: 0686450820
- Email: Eva.Deveze@chu-angers.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with a completed form
|
Patients have to complete these two forms, Quick DASH and SF-36, before surgery then 6 weeks after
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Results before surgery and at 6 weeks after surgery are compared
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Results before surgery and at 6 weeks after surgery are compared
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 5, 2022
Primary Completion (Anticipated)
March 14, 2025
Study Completion (Anticipated)
August 17, 2026
Study Registration Dates
First Submitted
June 10, 2022
First Submitted That Met QC Criteria
June 21, 2022
First Posted (Actual)
June 22, 2022
Study Record Updates
Last Update Posted (Estimate)
December 12, 2022
Last Update Submitted That Met QC Criteria
December 8, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-A01379-34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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