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NCT Number: NCT06172101

Free Fat Flap In Recurrent Neurogenic Thoracic Outlet Syndrome Surgical Treatment

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr Lancien

Nantes, 44000, France

Location status: Recruiting

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Free fat flap

Other

Free fat flap In Recurrent neurogenic thoracic outlet syndrome Surgical Treatment

Primary outcomes

  1. Evaluating the impact on pain of covering the brachial plexus with a free fat flap

    Time frame: pre-op and six months post-op

    the percentage reduction in pain assessed by a numerical scale from 0 to 10

Study contacts

Contact information is provided by the study sponsor or research team.

François Thuau

CONTACT

[email protected]

+33 2 40 08 73 04

Ugo Lancien, M.D

CONTACT

[email protected]

+33 2 40 08 73 04

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: FIRST

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 15, 2023
Registry last updated
Jul 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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