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

Sponsor
University Hospital, Angers (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06036888
Collaborator
(none)
50
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionaries completion

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
DEFILE-QoL5 - Evaluation de la Prise en Charge Chirurgicale à 5 Ans du Syndrome du défilé Thoraco-brachial
Anticipated Study Start Date :
Sep 15, 2023
Anticipated Primary Completion Date :
Mar 15, 2024
Anticipated Study Completion Date :
Mar 15, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Quality of life scores [at least 5 years after surgery]

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

Secondary Outcome Measures

  1. Factors associated with poor long-term clinical outcome [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Angers

Investigators

  • Study Director: Cécile Jaglin-Grimonprez, University hospital of Angers

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Angers
ClinicalTrials.gov Identifier:
NCT06036888
Other Study ID Numbers:
  • 2023-A00126-39
First Posted:
Sep 14, 2023
Last Update Posted:
Sep 14, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 14, 2023