Thoracic Outlet SyndromeDEFILE-QoL5NCT06036888
DEFILE-QoL5 - Evaluation of the Long-term Surgical Management of the Thoraco-brachial Displacement Syndrome
An observational study of Thoracic Outlet Syndrome, run by University Hospital, Angers at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic Outlet Syndrome
- What is being tested?
- questionaries completion
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed for thoraco-brachial outlet syndrome and treated surgically in the department of university Angers hospital in 2016
Who may be able to join
- Adult
- having participated in the initial study : "DEFILE-QoL"
Who cannot join
- opposing participation in the research
- unable to answer questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Thoracic Outlet Syndrome
- Being tested
- questionaries completion
- Medical subject headings
- Thoracic Outlet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionaries completionOther
Answer to the DASH and SF-12 questionaries, for an estimated duration of 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: questionaries completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life scores
Assess the quality of life, using standardized questionnaires, of patients treated surgically for thoraco-brachial outlet syndrome
Measured: at least 5 years after surgery
Secondary outcomes (1)
Factors associated with poor long-term clinical outcome
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
Measured: at least 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start6 Nov 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic Outlet SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Cécile Jaglin-Grimonprez, Study director, University hospital of Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036888
- Sponsor's protocol ID
- 2023-A00126-39
- Acronym
- DEFILE-QoL5
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DEFILE-QoL5 - Evaluation de la Prise en Charge Chirurgicale à 5 Ans du Syndrome du défilé Thoraco-brachial
- ClinicalTrials.gov ID
- NCT06036888
- Acronym / sponsor ID
- DEFILE-QoL5 / 2023-A00126-39
- Conditions
- Thoracic Outlet Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thoracobrachial outlet syndrome | – | Other: questionaries completionPatient : * 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed for thoraco-brachial outlet syndrome and treated surgically in the department of university Angers hospital in 2016
Key inclusion criteria (2 listed)
- Adult
- having participated in the initial study : "DEFILE-QoL"
Key exclusion criteria (2 listed)
- opposing participation in the research
- unable to answer questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionaries completionAnswer to the DASH and SF-12 questionaries, for an estimated duration of 15 minutes. | Other | thoracobrachial outlet syndrome |
Primary outcome
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
1 secondary outcome
Factors associated with poor long-term clinical outcome
Time frame: at least 5 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cécile Jaglin-Grimonprez study director
University hospital of Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Outlet Syndrome, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life scores (time frame: at least 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.