Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06172101
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-12-07
Brief Title:
Free Fat Flap In Recurrent Neurogenic Thoracic Outlet Syndrome Surgical Treatment
Sponsor:
Nantes University Hospital
Organization:
Nantes University Hospital
Study Overview
Official Title:
Prospective Evaluation of Improvement in Pain and Quality of Life After Free Fat Flap for Treatment of Recurrent Neurological Thoracobrachial Outlet Syndrome
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FIRST
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 andor 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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None