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NCT Number: NCT06036888

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

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.

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Key information

Conditions

Thoracic Outlet Syndrome Cardiovascular Diseases Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Myriam AMMI

Angers, Maine Et Loire, 49933, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • opposing participation in the research
  • unable to answer questionnaires

Treatment and study plan

questionaries completion

Other

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

Primary outcomes

  1. Quality of life scores

    Time frame: at least 5 years after surgery

    Assess the quality of life, using standardized questionnaires, of patients treated surgically for thoraco-brachial outlet syndrome

Secondary outcomes

  1. Factors associated with poor long-term clinical outcome

    Time frame: at least 5 years after surgery

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Angers

Other Gov

Registry information

Official study title

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

Acronym: DEFILE-QoL5

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 14, 2023
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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