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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06172101
Other study ID # AP_UL_001
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.


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Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT03748602 - Surgical Thoracic Outlet Decompression for Neurogenic Thoracic Outlet Syndrome N/A