Free Fat Flap In Recurrent Neurogenic Thoracic Outlet Syndrome Surgical Treatment

Recruiting

• Conditions: Neurogenic Thoracic Outlet Syndrome

• Registration Number: NCT06172101
• Lead Sponsor: Nantes University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2023-12-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-19
• Primary Completion: 2026-05-18
• Study Completion: 2026-05-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluating the impact on pain of covering the brachial plexus with a free fat flap	pre-op and six months post-op	the percentage reduction in pain assessed by a numerical scale from 0 to 10

Trial Locations

Locations (1)

Dr Lancien; 🇫🇷 Nantes, France