Free Fat Flap In Recurrent Neurogenic Thoracic Outlet Syndrome Surgical Treatment (FIRST)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Neurogenic Thoracic Outlet Syndrome
• Intervention / Treatment: Other: Free fat flap

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Ugo Lancien, M.D; Phone Number: +33 2 40 08 73 04; Email: ugo.lancien@ch-nantes.fr
• Study Contact Backup: Name: François Thuau; Phone Number: +33 2 40 08 73 04; Email: francois.thuau@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients operated on for brachial plexus neurolysis and free fat flap coverage in the setting of recurrent neurological thoracic brachial outlet syndrome.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Estimated): December 15, 2023

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Free fat flap; Recurrent neurogenic thoracic outlet syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Disease; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Syndrome; Thoracic Outlet Syndrome
• Other Study ID Numbers: AP_UL_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No