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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06036888
Acronym
DEFILE-QoL5
Enrollment
53
Registered
2023-09-14
Start date
2023-11-06
Completion date
2023-12-31
Last updated
2026-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Outlet Syndrome

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.

Interventions

OTHERquestionaries completion

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

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* opposing participation in the research * unable to answer questionnaires

Design outcomes

Primary

MeasureTime frameDescription
Quality of life scoresat least 5 years after surgeryAssess the quality of life, using standardized questionnaires, of patients treated surgically for thoraco-brachial outlet syndrome

Secondary

MeasureTime frameDescription
Factors associated with poor long-term clinical outcomeat least 5 years after surgeryIdentify 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

Countries

France

Contacts

STUDY_DIRECTORCécile Jaglin-Grimonprez

University hospital of Angers

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026