Free Fat Flap In Recurrent Neurogenic Thoracic Outlet Syndrome Surgical Treatment

Neurogenic Thoracic Outlet Syndrome Clinical Trial

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Official title:

Prospective Evaluation of Improvement in Pain and Quality of Life After Free Fat Flap for Treatment of Recurrent Neurological Thoracobrachial Outlet Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06172101
• Other study ID #: AP_UL_001
• Status: Not yet recruiting
• Start date: December 2023
• Est. completion date: June 2025

Study information

• Verified date: December 2023
• Source: Nantes University Hospital
• Contact: Ugo Lancien, M.D
• Phone: +33 2 40 08 73 04
• Email: ugo.lancien[@]ch-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Thoraco-Brachial Outlet Syndrome (T-BOS) corresponds to the entirety of clinical manifestations related to the compression of the branches of the brachial plexus and/or the subclavian vessels during their passage through the cervico-thoracic region.

Following surgery, a recurrence of symptoms occurs in 5% to 30% of operated patients. The treatment of these recurrences primarily relies on conservative therapies, and in case of failure, surgical intervention, particularly neurolysis of the brachial plexus.

In order to prevent a new recurrence, it is desirable to cover the neurolyzed brachial plexus with a flap, providing better local vascularization. However, fatty perforating flaps, by avoiding muscle harvesting, reduce donor site sequelae. We aim to investigate, through validated and recommended questionnaires, the impact of covering the neurolyzed brachial plexus with a free fatty flap after neurolysis in the context of recurrent neurological Thoraco-Brachial Outlet Syndrome.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients underwent brachial plexus neurolysis and free fat flap coverage in the context of recurrence of neurological thoraco-brachial outlet syndrome

Exclusion Criteria:

• Patients were unable to express their non-opposition to participating in the study.

• patients under guardianship or trusteeship.

• patients whose mother tongue is not French.

• patients who cannot read and/or write.

Related Conditions & MeSH terms

• Neurogenic Thoracic Outlet Syndrome
• Syndrome
• Thoracic Outlet Syndrome

Intervention

Other:
• Free fat flap
Free fat flap In Recurrent neurogenic thoracic outlet syndrome Surgical Treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the impact on pain of covering the brachial plexus with a free fat flap	the percentage reduction in pain assessed by a numerical scale from 0 to 10	pre-op and six months post-op