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

September 11, 2023 updated by: University Hospital, Angers

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • opposing participation in the research
  • unable to answer questionnaires

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at least 5 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at least 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2023

Primary Completion (Estimated)

March 15, 2024

Study Completion (Estimated)

March 15, 2024

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

September 11, 2023

First Posted (Actual)

September 14, 2023

Study Record Updates

Last Update Posted (Actual)

September 14, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A00126-39

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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