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

NCT06036888 | Completed

• 1 other identifier: 2023-A00126-39
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Outlet Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Factors associated with poor long-term clinical outcome

  at least 5 years after surgery

Study Arms (1)

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

Other: questionaries completion

Interventions

questionaries completion OTHER

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

thoracobrachial outlet syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed for thoraco-brachial outlet syndrome and treated surgically in the department of university Angers hospital in 2016

You may qualify if:

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

You may not qualify if:

• opposing participation in the research
• unable to answer questionnaires

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Myriam AMMI

Angers, Maine Et Loire, 49933, France

Location

MeSH Terms

Conditions

Thoracic Outlet Syndrome

Condition Hierarchy (Ancestors)

Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Cécile Jaglin-Grimonprez

  University hospital of Angers

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 14, 2023
• Study Start: November 6, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

FR (1)