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

NCT ID: NCT06036888

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2024-05-05

Brief 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.

Detailed 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.

Conditions

Thoracic Outlet Syndrome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

thoracobrachial outlet syndrome

Patient :

• adult
• with thoraco-brachial outlet syndrome
• who has participated to DEFILE-QoL study in 2016
• who accept to participate and is able to complete questionaries

questionaries completion

Intervention Type: OTHER

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

Interventions

questionaries completion

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• opposing participation in the research
• unable to answer questionnaires

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cécile Jaglin-Grimonprez

Role: STUDY_DIRECTOR

University hospital of Angers

Locations

Myriam AMMI

Angers, Maine Et Loire, France

Countries

France

Other Identifiers

2023-A00126-39

Identifier Type: -

Identifier Source: org_study_id