DEFILE-QoL5 - Evaluation of the Long-term Surgical Management of the Thoraco-brachial Displacement Syndrome

Thoracic Outlet Syndrome Clinical Trial

— DEFILE-QoL5  

Official title:

DEFILE-QoL5 - Evaluation de la Prise en Charge Chirurgicale à 5 Ans du Syndrome du défilé Thoraco-brachial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06036888
• Other study ID #: 2023-A00126-39
• Status: Completed
• Start date: November 6, 2023
• Est. completion date: May 5, 2024

Study information

• Verified date: June 2024
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study concerns patients hospitalized in vascular and thoracic surgery in 2016 at the University Hospital of Angers for the management of a thoraco-brachial outlet syndrome. It includes all vascular and neurological manifestations related to intermittent or permanent compression of the vasculo-nervous bundle of the upper limb. Before and after the operation, these patients had agreed to complete the quality of life questionnaires, the Disabilities of the Arm, Shoulder and Hand questionary (DASH) and the Short-Form 12 (SF-12). The objective of the present study is to evaluate the long-term quality of life, using the questionnaires mentioned above, completed by 54 patients treated surgically for thoraco-brachial outlet syndrome and who participated in the DEFILE-QoL study in 2016.

Description:

All patients included in the DEFILE-QoL study (in 2016) receive an information letter. Without opposition from them after 4 weeks, they are contacted by telephone. The telephone interview begins with an explanation of the study and a time to answer any questions from the patient.

If they agree to participate, they answer the DASH and the SF-12 questionnaires, for an estimated duration of 15 minutes. Following the telephone interview, the patient's participation in the study was terminated.

The date of the information and the patient's non-objection are documented in the patient's source file.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 5, 2024
• Est. primary completion date: May 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult

• having participated in the initial study : "DEFILE-QoL"

Exclusion Criteria:

• opposing participation in the research

• unable to answer questionnaires

Related Conditions & MeSH terms

• Syndrome
• Thoracic Outlet Syndrome

Intervention

Other:
• questionaries completion
Answer to the DASH and SF-12 questionaries, for an estimated duration of 15 minutes.

Locations

Country	Name	City	State
France	Myriam AMMI	Angers	Maine Et Loire

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life scores	Assess the quality of life, using standardized questionnaires, of patients treated surgically for thoraco-brachial outlet syndrome	at least 5 years after surgery
Secondary	Factors associated with poor long-term clinical outcome	Identify factors associated with poor long-term clinical outcome (DEFILE-QoL in 2016) : clinical presentation of Syndrome, its severity, the imaging examinations performed and the various scores collected	at least 5 years after surgery