Free fat flap transfer in recurrent neurogenic thoracic outlet syndrome pain treatment: FIRST study

Free fat flap transfer in recurrent neurogenic thoracic outlet syndrome pain treatment: FIRST study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Free fat flap transfer in recurrent neurogenic thoracic outlet syndrome pain treatment: FIRST study François Thuau, Guillaume Gadbled, Thomas Goronflot, Pierre Perrot, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5166504/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Neurogenic thoracic outlet syndrome (NTOS), characterized by brachial plexus compression, causes chronic pain and numbness in the upper extremities. Recurrences are common after surgical treatment, which typically includes an anterior scalenectomy and rib resection. Brachial plexus neurolysis and flap coverage can reduce scar fibrosis and prevent further recurrence. The latissimus dorsi flap is a common choice for this purpose. However, perforator fat flaps minimize donor site complications by avoiding muscle harvesting. Furthermore, a free flap transfer prevents new scars from developing in an already painful anatomical region. Given the lack of literature on this subject, we plan to use validated and recommended questionnaires to investigate the impact on pain and quality of life of brachial plexus wrapping with a free fat flap following neurolysis in cases of recurrent NTOS (R-NOS). Methods: FIRST is a single-center, prospective observational study recruiting participants over 24 months. Eligible patients over the age of 18 are treated with brachial plexus neurolysis and a free perforator fat flap for R-NTOS. The study aims to enroll 20 patients and involves preoperative and postoperative assessments at a six-month follow-up. The primary outcome, measured using numerical scales, is pain reduction. Secondary outcomes include decreased painful body surface area, maximum and average pain levels, changes in quality of life (QoL), upper limb function, and anxiety-depressive symptoms, which are measured using various validated scales and questionnaires. Discussion: The novelty of this study lies in its ability to provide information on the impact of free perforator fat flaps in R-NTOS treatment using validated, standardized and recommended methods of assessment for neuropathic pain, particularly considering the psychosocial impact. Recurrent Neurogenic Thoracic Outlet Syndrome Pain Brachial plexus Free perforator flap Neurolysis Microsurgery. Figures Figure 1 Figure 2 Background Thoracic outlet syndrome (TOS) was first described in 1956 [ 1 ] by Peet et al. as a heterogeneous characterization of symptoms associated with thoracic outlet neurovascular compression. This can cause chronic pain, numbness, and paresthesia in the neck, upper back, and upper extremities [ 2 , 3 ]. TOS is a relatively rare syndrome (1–3 per 100,000) that is classified according to the structure constricted: neurogenic (NTOS), arterial (ATOS), or venous (VTOS). NTOS accounts for approximately 90% of all forms of TOS [ 4 ] and leads to significant debilitation. Patients with NTOS experience a level of impairment similar to those with chronic heart failure, with mean Short-Form 12 (SF-12) Physical Component Scores (PCS) and Mental Component Scores (MCS) below the population norm [ 5 ]. The most common surgical treatment is compression release with anterior scalenectomy, which may be combined with a first rib resection [ 6 ]. However, symptoms recur in 5–30% of operated patients [ 7 ]. These recurrences are frequently associated with scar fibrosis surrounding the brachial plexus nerves responsible for their compression. Recurrences are primarily treated with conservative therapies, and if those fail, with another surgery, most notably brachial plexus neurolysis. It is advisable to employ a flap to cover the neurolyzed brachial plexus to prevent further recurrences. This approach enhances local vascularization, provides protection against external compression of nerves, and restricts scar fibrosis. The classic choice for this indication is the pedicled latissimus dorsi muscle flap [ 8 ]. Fat perforator flaps, on the other hand, offer an alternative approach that minimizes donor site sequelae by eliminating the need for muscle harvesting [ 9 ]. Since their description in the 90s, perforator flaps have become the gold standard for soft tissue reconstruction, as their harvesting spares important soft tissues ( i.e ., muscles, nerves) and typically includes skin and subcutaneous fat tissue. Furthermore, the free transfer of the perforator flap prevents the formation of new scars in an already painful anatomical region. The literature lacks studies on wrapping the brachial plexus using perforator flaps, creating a gap in our understanding of this surgical procedure. Additionally, there is limited knowledge about the long-term function and quality of life (QoL) in patients undergoing surgery for recurrent neurogenic thoracic outlet syndrome (R-NTOS). By utilizing validated and recommended questionnaires, our investigation seeks to assess the impact of wrapping the brachial plexus with a free perforator fat flap after neurolysis in the context of R-NTOS on pain and QoL outcomes. Methods/design Study design The FIRST (Free fat flap In Recurrent neurogenic thoracic outlet Syndrome pain Treatment) clinical trial is a prospective observational single-center study conducted at Nantes University Hospital, France. The protocol has been written in compliance with SPIRIT recommendations. This study is being conducted in two departments, one of plastic surgery and one of orthopedic surgery, both of which are familiar with NTOS surgery and the challenges of recurrent symptoms. The collaboration between these departments is essential for managing this condition, as the procedure requires the expertise of two surgeons in the operating room. Study Population Description of the population and recruitment for the trial Recruitment is planned over 24 months. Patients of both sexes, aged over 18 years undergoing brachial plexus neurolysis and wrapping with a free perforator fat flap for R-NTOS will be offered the FIRST protocol. Patients whose first language is not French, who cannot read or write, and who are under guardianship or trusteeship are excluded. Study schedule The study plan described in this section is presented in Fig. 1. During the routine preoperative consultation with the surgeon (between 180 and 30 days before surgery), the surgeon introduces the study to the patient and obtains informed consent. The day before the operation (D-1), patients will complete inpatient questionnaires on pain and quality of life (QoL). Firstly, the patient must indicate the location of their pain. Patients will then rate the intensity of their pain on three numerical scales (NS): current pain, usual pain over the last eight days, and most intense pain in the previous eight days (from 0, no pain, to 10, maximum pain imaginable). The patient will also complete the short form of the "Questionnaire Douleur de Saint-Antoine" (QDSA). Following the pain assessment, the patient will fill out the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire to evaluate the functional status of their upper limb. Finally, the patient will complete QoL questionnaires, including the SF-36 and the Hospital Anxiety and Depression Scale (HADS). During the routine postoperative consultation with the surgeon six months after surgery, the following information will be collected: · Surgery area complications (e.g., hematoma, infection, wound dehiscence, partial or total flap loss, necrosis, need for surgical revision) · Flap donor site complications (e.g., wound dehiscence, hematoma, lymphocele) · Responses to the same D-1 questionnaires (pain levels, QDSA, DASH, SF-36, HADS) The flowchart for the study is shown in Fig. 2. Objectives and outcomes Objectives The main objective of this study is to assess the impact of wrapping the brachial plexus with a free perforator fat flap after neurolysis in the context of R-NTOS on pain, measured between baseline (D-1) and six months post-surgery. The secondary objectives include evaluating the impact of the surgical procedure on: 1. Pain localization. 2. Maximum pain experienced in the last eight days. 3. Average pain felt over the last eight days. 4. Symptoms of neuropathic pain. 5. Use of analgesic treatment. 6. Quality of life. 7. Upper limb function. 8. Anxiety-depressive symptoms. 9. Safety of the free fat flaps (adverse effects). Outcomes The primary outcome is the reduction in pain, measured before and six months after surgery using a numerical scale ranging from 0 to 10. Similarly, the secondary outcomes, also measured before and six months after surgery, are: 1. Reduction in painful body surface area assessed using a pain area diagram. 2. Decrease in maximum pain experienced in the previous eight days on a numerical scale of 0 to 10. 3. Reduction in average pain experienced over the last eight days on a numerical scale of 0 to 10. 4. Decrease in the intensity of items on the short version of the Questionnaire Douleur de Saint-Antoine (QDSA). 5. Reduction in analgesic consumption (number of drugs, dose, frequency, dose/day ratio) as reported in the patient's diary. 6. Improvement in quality of life using the SF-36 self-questionnaire. 7. Improvement in upper limb function assessed with the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. 8. Improvement in anxiety-depressive symptoms measured with the Hospital Anxiety and Depression Scale (HADS). 9. Resolution of adverse events between baseline (D-1) and 6 months after surgery. Measures used to determine the outcomes The QDSA (short form) assesses pain description using a multidimensional verbal scale comprising 16 adjectives rated from 0 (absent) to 4 (extremely strong). It also evaluates pain intensity and the experience of anxiety and depression. The questionnaire is an adaptation in French[10] of the McGill Pain Questionnaire (MPQ) developed by Melzack and Wall [11]. The SF-36 questionnaire consists of 36 items and evaluates eight dimensions of health, with scores ranging from 0 to 100. It is widely used in clinical research and public health to assess quality of life (QoL) [12] validated in French [13]. A QoL score below 66 indicates impairment. The DASH questionnaire includes 30 items rated from 0 (best score) to 100 (worst score), assessing upper limb function and discomfort in leisure and work activities. Developed in North America in 1994, it was translated and validated in French by Dubert et al. in 2001 [14]. The HADS is used to assess levels of anxiety and depression with 14 items rated from 0 to 3. Developed by Zigmond and Snaith in 1983 [15], it provides separate scores for anxiety (A) and depression (D). Scores of 7 or less indicate no symptoms, 8 to 10 suggest doubtful symptomatology, and 11 or more indicate definite symptomatology [16]. Statistical methods All pre- and post-operative data will be analyzed descriptively. The 95% confidence intervals for qualitative variables will be reported as numbers and percentages. Depending on the distribution of variables, quantitative data will be presented as mean with standard deviation or median with interquartile range. A non-parametric Wilcoxon test will be utilized to conduct univariate analysis of the primary and secondary quantitative endpoints between pre- and post-operative data. The significance threshold for p-values will be set at 0.05. Statistical analyses will be performed using RStudio software. Patients size The number of patients is challenging to determine due to the rarity of the surgical indication. However, we estimate that approximately 20 patients will be needed for this study. This estimation is based on expecting a mean difference of -3 for our primary endpoint, with a standard deviation of 2. We have set the beta risk at 20% and the alpha risk at 5%. Adverse event (AE) management No additional procedures beyond standard care will be performed during the study. In case of an adverse event related to the patient's care occurring under the current protocol, it will be promptly reported to the appropriate vigilance system (such as pharmacovigilance, biovigilance, hemovigilance, materiovigilance, etc.). Ensuring the safety of the procedure is a secondary objective. All adverse events observed by the investigator or reported by the subjects during the study will be documented in the adverse event section of the Case Report Form (CRF). Ethical, regulatory, and dissemination aspects The clinical study will be conducted in accordance with the relevant versions of the French Public Health Code, national and international Good Clinical Practice guidelines, and the Declaration of Helsinki, as applicable. Approval for this clinical study was obtained from the local Ethical Board of Nantes (GNEDS - Groupement Nantais d’Ethique dans le Domaine de la Santé) on October 2, 2023 (refer to Additional file for the French informed consent). Data collected during the study will be electronically processed in compliance with the requirements of the CNIL, the French Data Protection Authority (in accordance with the French Reference Methodology MR004). The amended protocol should be a dated, updated version. If necessary, the information form and consent form should be amended. The updated protocol is at version 1 on 17 September 2023 The protocol and trial have been made possible by an Executive Committee, which includes a Scientific Committee and a Steering Committee. The Scientific Committee, led by Dr. Ugo Lancien M.D., M.Sc. and François Thuau, includes Nantes experts in this pathology: Dr. Guillaume Gadbled M.D. and Prof. Pierre Perrot M.D., Ph.D., along with a biostatistician, a methodologist, and the project manager. The Steering Committee comprises members of the Scientific Committee, as well as the data management team and the nurse study coordinator from the Plastic Surgery Department. Trial results will be published in international surgical, medical, and scientific journals, and presented at national and international conferences. The investigators will adhere to the rules and guidelines of the International Committee for Medical Journal Editors (ICMJE) when sharing the entirety of the final trial dataset. Discussion Our innovative study focuses on the use of free perforator fat flaps to wrap the brachial plexus following neurolysis in cases of recurrent neurogenic thoracic outlet syndrome (R-NTOS). We emphasize the importance of preserving donor site integrity while minimizing local dissection to prevent exacerbating fibrosis. Moreover, our wrapping technique has demonstrated effectiveness in reducing the recurrence of postoperative fibrosis [ 17 ]. The study employs validated, standardized, and recommended methods for evaluating neuropathic pain, taking into account its psychosocial impact. However, it is crucial to note that this approach necessitates extended operative time and the expertise of a double surgical team with precise microsurgical skills. Furthermore, the availability of suitable recipient vessels becomes critical following certain decompression procedures, such as resection of the thyrocervical trunk or cervical transverse. Our primary objective is to assess the impact on pain of wrapping the brachial plexus with a free perforator fat flap after neurolysis in the context of neurogenic thoracic outlet syndrome (NTOS), from baseline (Day − 1) to six months post-surgery. This six-month period is essential for evaluating postoperative outcomes thoroughly. We would like to highlight that alternative interventions using pedicled flaps (e.g., latissimus dorsi, omentum[ 18 ] or deltopectoral flaps [ 19 ]) pose significant drawbacks such as functional impairment, abdominal incision, or concerns regarding thoracic aesthetics. In conclusion, this study serves as a pilot phase intended to pave the way for a larger randomized trial to validate our findings and provide more robust recommendations for managing R-NTOS. Additionally, we aim to assess the medical-economic impact of this longer surgical procedure involving two surgical teams in the operating room, which we believe will result in fewer recurrences and associated consequences, such as work stoppage. Trial status This trial is still ongoing; patient inclusion is not yet complete. The updated protocol is at version 1 on 17 September 2023. The first patient was included on 18 December 2023. Recruitment by the investigating center will continue until 24 months and the study period will end on 18 May 2026. Abbreviations AE Adverse event ATOS Arterial thoracic outlet syndrome CNIL Commission nationale de l'informatique et des libertés DASH Disabilities of the Arm, Shoulder, and Hand FIRST Free fat flap In Recurrent neurogenic thoracic outlet Syndrome pain Treatment GNEDS Groupement Nantais d’Ethique dans le Domaine de la Santé HADS Hospital Anxiety and Depression Scale ICMJE International Committee for Medical Journal Editors MCS Mental component status MPQ McGill pain questionnaire NS Numerical scales NTOS Neurogenic thoracic outlet syndrome PCS Physical component status QDSA Questionnaire de douleur de Saint-Antoine QoL Quality of Life RNTOS Recurrent neurogenic thoracic outlet syndrome SF-12 Short-Form 12 SF-36 Short-Form 36 TOS Thoracic outlet syndrome VTOS Veinous thoracic outlet syndrome Declarations Ethics approval and consent to participate This clinical study was submitted to and approved by the local Ethical Board of Nantes (GNEDS- Groupement Nantais d’Ethique dans le Domaine de la Santé) on October, 2nd 2023 Clinical trial number: Trial registration : NCT06172101 first registration 12/07/2023 Consent for publication Not applicable — no identifying images or other personal or clinical details of participants are presented here Consent to Participate declaration : All the patients have provided their consent. Availability of data and materials : Data collected during the test may be processed electronically, following the requirements of CNIL (compliance with reference methodology MR004). The investigators will share the entirety of the final trial dataset Competing interests : There are no financial or competing interests to be declared for the investigators. Funding : This study is an academic study with no funder and sponsored by the CHU Nantes Authors' contributions : UL and FT designed the trial, FT, GG, UL wrote the protocol, AP, UL, FT wrote the manuscript. GG, TG and PP assisted with the drafting of the manuscript. TG wrote the methodological/statistical analyses in the protocol. All authors read and approved the final manuscript References Peet RM, Henriksen JD, Anderson TP, Martin GM. Thoracic-outlet syndrome: evaluation of a therapeutic exercise program. Proc Staff Meet Mayo Clin. 1956;31:281–7. Illig KA, Rodriguez-Zoppi E. How Common Is Thoracic Outlet Syndrome? Thoracic Surgery Clinics. 2021;31:11–7. Thompson RW. Challenges in the Treatment of Thoracic Outlet Syndrome. Tex Heart Inst J. 2012;39:842–3. Sanders RJ, Hammond SL, Rao NM. Diagnosis of thoracic outlet syndrome. Journal of Vascular Surgery. 2007;46:601–4. Chang DC, Rotellini-Coltvet LA, Mukherjee D, De Leon R, Freischlag JA. Surgical intervention for thoracic outlet syndrome improves patient’s quality of life. J Vasc Surg. 2009;49:630–5; discussion 635-637. Weaver M, Lum Y. New Diagnostic and Treatment Modalities for Neurogenic Thoracic Outlet Syndrome. Diagnostics. 2017;7:28. Jammeh ML, Yang A, Abuirqeba AA, Ohman JW, Thompson RW. Reoperative Brachial Plexus Neurolysis After Previous Anatomically Complete Supraclavicular Decompression for Neurogenic Thoracic Outlet Syndrome: A 10-Year Single-Center Case Series. Operative Neurosurgery. 2022;23:125–32. Annest SJ, Sanders RJ. Assessment and Treatment of Recurrent NTOS. In: Illig KA, Thompson RW, Freischlag JA, Donahue DM, Jordan SE, Edgelow PI, editors. Thoracic Outlet Syndrome [Internet]. London: Springer London; 2013 [cited 2023 Sep 18]. p. 281–9. Available from: https://link.springer.com/10.1007/978-1-4471-4366-6_39 Lee K-T, Mun G-H. A Systematic Review of Functional Donor-Site Morbidity after Latissimus Dorsi Muscle Transfer: Plastic and Reconstructive Surgery. 2014;134:303–14. Boureau F, Luu M, Doubrere JF, Gay C. [Construction of a questionnaire for the self-evaluation of pain using a list of qualifiers. Comparison with Melzack’s McGill Pain Questionnaire]. Therapie. 1984;39:119–29. Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975;1:277–99. Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473–83. Leplège A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998;51:1013–23. Dubert T, Voche P, Dumontier C, Dinh A. Le questionnaire DASH. Adaptation française d’un outil d’évaluation international. Chirurgie de la Main. 2001;20:294–302. Zigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361–70. Novak CB, Katz J. Neuropathic Pain in Patients with Upper-Extremity Nerve Injury. Physiotherapy Canada. 2010;62:190–201. Elliot D, Lloyd M, Hazari A, Sauerland S, Anand P. Relief of the pain of neuromas-in-continuity and scarred median and ulnar nerves in the distal forearm and wrist by neurolysis, wrapping in vascularized forearm fascial flaps and adjunctive procedures. J Hand Surg Eur Vol. 2010;35:575–82. Brunelli G, Brunelli F. Surgical Treatment of Actinic Brachial Plexus Lesions: Free Microvascular Transfer of the Greater Omentum. J reconstr Microsurg. 1985;1:197–200. Dolan RT, Moosa A, Giele HP. The Adipofascial Deltopectoral Flap to Cover the Brachial Plexus in Thoracic Outlet Syndrome and Radiation Plexitis. Journal of Plastic, Reconstructive & Aesthetic Surgery. 2020;73:1465–72. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5166504","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":361973758,"identity":"3bfb0b68-a4c1-45d9-8639-87db76c55a84","order_by":0,"name":"François Thuau","email":"","orcid":"","institution":"Nantes University, CHU Nantes, Plastic Reconstructive, and Aesthetic Surgery Department, Nantes, FRANCE","correspondingAuthor":false,"prefix":"","firstName":"François","middleName":"","lastName":"Thuau","suffix":""},{"id":361973759,"identity":"13d52e4a-f654-436b-a239-df55b254e91b","order_by":1,"name":"Guillaume Gadbled","email":"","orcid":"","institution":"Nantes University, CHU Nantes, Orthopedic and Traumatology Surgery Department, Nantes, FRANCE.","correspondingAuthor":false,"prefix":"","firstName":"Guillaume","middleName":"","lastName":"Gadbled","suffix":""},{"id":361973760,"identity":"7e4a06ec-87dd-4221-a55e-a7a21fc4c7ea","order_by":2,"name":"Thomas Goronflot","email":"","orcid":"","institution":"Nantes University, CHU Nantes, Pôle Hospitalo-Universitaire 11 : Santé Publique, Clinique des données, INSERM, CIC 1413, 44000 Nantes, FRANCE","correspondingAuthor":false,"prefix":"","firstName":"Thomas","middleName":"","lastName":"Goronflot","suffix":""},{"id":361973761,"identity":"ef2147aa-c0dc-455f-8b78-4751adbf33e5","order_by":3,"name":"Pierre Perrot","email":"","orcid":"","institution":"Nantes University, CHU Nantes, Plastic Reconstructive, and Aesthetic Surgery Department, Nantes, FRANCE","correspondingAuthor":false,"prefix":"","firstName":"Pierre","middleName":"","lastName":"Perrot","suffix":""},{"id":361973762,"identity":"9176868d-4a24-4f2c-87c3-0182f02104be","order_by":4,"name":"Alexandra Poinas","email":"","orcid":"","institution":"Nantes University, CHU Nantes, INSERM CIC 1413 Investigation and translational Research Department, Research and Innovation Division, Nantes, FRANCE.","correspondingAuthor":false,"prefix":"","firstName":"Alexandra","middleName":"","lastName":"Poinas","suffix":""},{"id":361973763,"identity":"05d30de8-9365-4427-875f-5833c4d3ff04","order_by":5,"name":"Ugo Lancien","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAyElEQVRIiWNgGAWjYDACdhBhwMDAD6ITCojRwgzVItkA0mJAtBaQrgNQvQSBwWHmZw9+FNjkGZ9fnfjhgQGDPL/YAUJa2MwNewzSis1uvN0sAXSY4czZCYS0MJhJA8nEbTfObgBpSTC4TVAL+zeglv+Jm2ec3fyDSC08IFsOJG7g791GnC2Sh3nKJHsMkhNn3ODdZpFgIEHYL3zH27dJ/Phjl9jff3bzzR8VNvL80gS0IIAEWKUEscpBgP8AKapHwSgYBaNgJAEAp1ZCI+g1/U4AAAAASUVORK5CYII=","orcid":"","institution":"Nantes University, CHU Nantes, Plastic Reconstructive, and Aesthetic Surgery Department, Nantes, FRANCE","correspondingAuthor":true,"prefix":"","firstName":"Ugo","middleName":"","lastName":"Lancien","suffix":""}],"badges":[],"createdAt":"2024-09-27 16:23:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5166504/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5166504/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":68716277,"identity":"2b7019b7-41db-4860-8997-b47c66f8edf6","added_by":"auto","created_at":"2024-11-11 09:56:51","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":17267,"visible":true,"origin":"","legend":"\u003cp\u003eStudy diagram\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5166504/v1/43f0e5506fef46e32e21118d.png"},{"id":68716278,"identity":"f3b2b8bb-940a-4a10-be18-83daccf02683","added_by":"auto","created_at":"2024-11-11 09:56:52","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":30065,"visible":true,"origin":"","legend":"\u003cp\u003eFlow chart of FIRST protocol\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-5166504/v1/5f9b666752db0dacfd0c8b26.png"},{"id":70698450,"identity":"6bd6c060-797d-46ed-8e1d-41b51bedd7ad","added_by":"auto","created_at":"2024-12-05 18:17:03","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":345161,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5166504/v1/47cb3cb3-9c60-4049-b7ba-de5d92c3837a.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Free fat flap transfer in recurrent neurogenic thoracic outlet syndrome pain treatment: FIRST study","fulltext":[{"header":"Background","content":"\u003cp\u003eThoracic outlet syndrome (TOS) was first described in 1956 [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e] by Peet \u003cem\u003eet al.\u003c/em\u003e as a heterogeneous characterization of symptoms associated with thoracic outlet neurovascular compression. This can cause chronic pain, numbness, and paresthesia in the neck, upper back, and upper extremities [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. TOS is a relatively rare syndrome (1\u0026ndash;3 per 100,000) that is classified according to the structure constricted: neurogenic (NTOS), arterial (ATOS), or venous (VTOS).\u003c/p\u003e \u003cp\u003eNTOS accounts for approximately 90% of all forms of TOS [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e] and leads to significant debilitation. Patients with NTOS experience a level of impairment similar to those with chronic heart failure, with mean Short-Form 12 (SF-12) Physical Component Scores (PCS) and Mental Component Scores (MCS) below the population norm [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe most common surgical treatment is compression release with anterior scalenectomy, which may be combined with a first rib resection [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. However, symptoms recur in 5\u0026ndash;30% of operated patients [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. These recurrences are frequently associated with scar fibrosis surrounding the brachial plexus nerves responsible for their compression. Recurrences are primarily treated with conservative therapies, and if those fail, with another surgery, most notably brachial plexus neurolysis. It is advisable to employ a flap to cover the neurolyzed brachial plexus to prevent further recurrences. This approach enhances local vascularization, provides protection against external compression of nerves, and restricts scar fibrosis. The classic choice for this indication is the pedicled latissimus dorsi muscle flap [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eFat perforator flaps, on the other hand, offer an alternative approach that minimizes donor site sequelae by eliminating the need for muscle harvesting [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. Since their description in the 90s, perforator flaps have become the gold standard for soft tissue reconstruction, as their harvesting spares important soft tissues (\u003cem\u003ei.e\u003c/em\u003e., muscles, nerves) and typically includes skin and subcutaneous fat tissue. Furthermore, the free transfer of the perforator flap prevents the formation of new scars in an already painful anatomical region.\u003c/p\u003e \u003cp\u003eThe literature lacks studies on wrapping the brachial plexus using perforator flaps, creating a gap in our understanding of this surgical procedure. Additionally, there is limited knowledge about the long-term function and quality of life (QoL) in patients undergoing surgery for recurrent neurogenic thoracic outlet syndrome (R-NTOS). By utilizing validated and recommended questionnaires, our investigation seeks to assess the impact of wrapping the brachial plexus with a free perforator fat flap after neurolysis in the context of R-NTOS on pain and QoL outcomes.\u003c/p\u003e"},{"header":"Methods/design","content":"\u003cp\u003e\u003cstrong\u003eStudy design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe FIRST (Free fat flap In Recurrent neurogenic thoracic outlet Syndrome pain Treatment) clinical trial is a prospective observational single-center study conducted at Nantes University Hospital, France. The protocol has been written in compliance with SPIRIT recommendations. This study is being conducted in two departments, one of plastic surgery and one of orthopedic surgery, both of which are familiar with NTOS surgery and the challenges of recurrent symptoms. The collaboration between these departments is essential for managing this condition, as the procedure requires the expertise of two surgeons in the operating room.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy Population\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eDescription of the population and recruitment for the trial\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eRecruitment is planned over 24 months. Patients of both sexes, aged over 18 years\u0026nbsp;undergoing brachial plexus neurolysis and wrapping with a free perforator fat flap for R-NTOS will be offered the FIRST protocol. Patients whose first language is not French, who cannot read or write, and who are under guardianship or trusteeship are excluded.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStudy schedule\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe study plan described in this section is presented in Fig. 1. During the routine preoperative consultation with the surgeon (between 180 and 30 days before surgery), the surgeon introduces the study to the patient and obtains informed consent. The day before the operation (D-1), patients will complete inpatient questionnaires on pain and quality of life (QoL). Firstly, the patient must indicate the location of their pain. Patients will then rate the intensity of their pain on three numerical scales (NS): current pain, usual pain over the last eight days, and most intense pain in the previous eight days (from 0, no pain, to 10, maximum pain imaginable). The patient will also complete the short form of the \"Questionnaire Douleur de Saint-Antoine\" (QDSA). Following the pain assessment, the patient will fill out the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire to evaluate the functional status of their upper limb. Finally, the patient will complete QoL questionnaires, including the SF-36 and the Hospital Anxiety and Depression Scale (HADS).\u003c/p\u003e\n\u003cp\u003eDuring the routine postoperative consultation with the surgeon six months after surgery, the following information will be collected:\u003c/p\u003e\n\u003cp\u003e·\u0026nbsp; \u0026nbsp;\u0026nbsp;Surgery area complications (e.g., hematoma, infection, wound dehiscence, partial or total flap loss, necrosis, need for surgical revision)\u003c/p\u003e\n\u003cp\u003e·\u0026nbsp; \u0026nbsp;\u0026nbsp;Flap donor site complications (e.g., wound dehiscence, hematoma, lymphocele)\u003c/p\u003e\n\u003cp\u003e·\u0026nbsp; \u0026nbsp;\u0026nbsp;Responses to the same D-1 questionnaires (pain levels, QDSA, DASH, SF-36, HADS)\u003c/p\u003e\n\u003cp\u003eThe flowchart for the study is shown in Fig. 2.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjectives and outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eObjectives\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe main objective of this study is to assess the impact of wrapping the brachial plexus with a free perforator fat flap after neurolysis in the context of R-NTOS on pain, measured between baseline (D-1) and six months post-surgery.\u003c/p\u003e\n\u003cp\u003eThe secondary objectives include evaluating the impact of the surgical procedure on:\u003c/p\u003e\n\u003cp\u003e1.\u0026nbsp; \u0026nbsp;Pain localization.\u003c/p\u003e\n\u003cp\u003e2.\u0026nbsp; \u0026nbsp;Maximum pain experienced in the last eight days.\u003c/p\u003e\n\u003cp\u003e3.\u0026nbsp; \u0026nbsp;Average pain felt over the last eight days.\u003c/p\u003e\n\u003cp\u003e4.\u0026nbsp; \u0026nbsp;Symptoms of neuropathic pain.\u003c/p\u003e\n\u003cp\u003e5.\u0026nbsp; \u0026nbsp;Use of analgesic treatment.\u003c/p\u003e\n\u003cp\u003e6.\u0026nbsp; \u0026nbsp;Quality of life.\u003c/p\u003e\n\u003cp\u003e7.\u0026nbsp; \u0026nbsp;Upper limb function.\u003c/p\u003e\n\u003cp\u003e8.\u0026nbsp; \u0026nbsp;Anxiety-depressive symptoms.\u003c/p\u003e\n\u003cp\u003e9.\u0026nbsp; \u0026nbsp;Safety of the free fat flaps (adverse effects).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eOutcomes\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe primary outcome is the reduction in pain, measured before and six months after surgery using a numerical scale ranging from 0 to 10.\u003c/p\u003e\n\u003cp\u003eSimilarly, the secondary outcomes, also measured before and six months after surgery, are:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e1.\u0026nbsp; \u0026nbsp;Reduction in painful body surface area assessed using a pain area diagram.\u003c/p\u003e\n\u003cp\u003e2.\u0026nbsp; \u0026nbsp;Decrease in maximum pain experienced in the previous eight days on a numerical scale of 0 to 10.\u003c/p\u003e\n\u003cp\u003e3.\u0026nbsp; \u0026nbsp;Reduction in average pain experienced over the last eight days on a numerical scale of 0 to 10.\u003c/p\u003e\n\u003cp\u003e4.\u0026nbsp; \u0026nbsp;Decrease in the intensity of items on the short version of the Questionnaire Douleur de Saint-Antoine (QDSA).\u003c/p\u003e\n\u003cp\u003e5.\u0026nbsp; \u0026nbsp;Reduction in analgesic consumption (number of drugs, dose, frequency, dose/day ratio) as reported in the patient's diary.\u003c/p\u003e\n\u003cp\u003e6.\u0026nbsp; \u0026nbsp;Improvement in quality of life using the SF-36 self-questionnaire.\u003c/p\u003e\n\u003cp\u003e7.\u0026nbsp; \u0026nbsp;Improvement in upper limb function assessed with the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.\u003c/p\u003e\n\u003cp\u003e8.\u0026nbsp; \u0026nbsp;Improvement in anxiety-depressive symptoms measured with the Hospital Anxiety and Depression Scale (HADS).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e9.\u0026nbsp; \u0026nbsp;\u003c/em\u003eResolution of adverse events between baseline (D-1) and 6 months after surgery.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eMeasures used to determine the outcomes\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe QDSA (short form) assesses pain description using a multidimensional verbal scale comprising 16 adjectives rated from 0 (absent) to 4 (extremely strong). It also evaluates pain intensity and the experience of anxiety and depression. The questionnaire is an adaptation in French[10]\u0026nbsp;of the McGill Pain Questionnaire (MPQ) developed by Melzack and Wall [11].\u003c/p\u003e\n\u003cp\u003eThe SF-36 questionnaire consists of 36 items and evaluates eight dimensions of health, with scores ranging from 0 to 100. It is widely used in clinical research and public health to assess quality of life (QoL)\u0026nbsp;[12]\u0026nbsp;validated in French\u0026nbsp;[13]. A QoL score below 66 indicates impairment.\u003c/p\u003e\n\u003cp\u003eThe DASH questionnaire includes 30 items rated from 0 (best score) to 100 (worst score), assessing upper limb function and discomfort in leisure and work activities. Developed in North America in 1994, it was translated and validated in French by Dubert et al. in 2001\u0026nbsp;[14].\u003c/p\u003e\n\u003cp\u003eThe HADS is used to assess levels of anxiety and depression with 14 items rated from 0 to 3. Developed by Zigmond and Snaith in 1983\u0026nbsp;[15], it provides separate scores for anxiety (A) and depression (D). Scores of 7 or less indicate no symptoms, 8 to 10 suggest doubtful symptomatology, and 11 or more indicate definite symptomatology\u0026nbsp;[16].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll pre- and post-operative data will be analyzed descriptively. The 95% confidence intervals for qualitative variables will be reported as numbers and percentages. Depending on the distribution of variables, quantitative data will be presented as mean with standard deviation or median with interquartile range.\u003c/p\u003e\n\u003cp\u003eA non-parametric Wilcoxon test will be utilized to conduct univariate analysis of the primary and secondary quantitative endpoints between pre- and post-operative data. The significance threshold for p-values will be set at 0.05. Statistical analyses will be performed using RStudio software.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatients size\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe number of patients is challenging to determine due to the rarity of the surgical indication. However, we estimate that approximately 20 patients will be needed for this study. This estimation is based on expecting a mean difference of -3 for our primary endpoint, with a standard deviation of 2. We have set the beta risk at 20% and the alpha risk at 5%.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdverse event (AE) management\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo additional procedures beyond standard care will be performed during the study. In case of an adverse event related to the patient's care occurring under the current protocol, it will be promptly reported to the appropriate vigilance system (such as pharmacovigilance, biovigilance, hemovigilance, materiovigilance, etc.). Ensuring the safety of the procedure is a secondary objective. All adverse events observed by the investigator or reported by the subjects during the study will be documented in the adverse event section of the Case Report Form (CRF).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical, regulatory, and dissemination aspects\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe clinical study will be conducted in accordance with the relevant versions of the French Public Health Code, national and international Good Clinical Practice guidelines, and the Declaration of Helsinki, as applicable. Approval for this clinical study was obtained from the local Ethical Board of Nantes (GNEDS - Groupement Nantais d’Ethique dans le Domaine de la Santé) on October 2, 2023 (refer to Additional file for the French informed consent).\u003c/p\u003e\n\u003cp\u003eData collected during the study will be electronically processed in compliance with the requirements of the CNIL, the French Data Protection Authority (in accordance with the French Reference Methodology MR004).\u003c/p\u003e\n\u003cp\u003eThe amended protocol should be a dated, updated version. If necessary, the information form and consent form should be amended. The updated protocol is at version 1 on 17 September 2023\u003c/p\u003e\n\u003cp\u003eThe protocol and trial have been made possible by an Executive Committee, which includes a Scientific Committee and a Steering Committee. The Scientific Committee, led by Dr. Ugo Lancien M.D., M.Sc. and François Thuau, includes Nantes experts in this pathology: Dr. Guillaume Gadbled M.D. and Prof. Pierre Perrot M.D., Ph.D., along with a biostatistician, a methodologist, and the project manager. The Steering Committee comprises members of the Scientific Committee, as well as the data management team and the nurse study coordinator from the Plastic Surgery Department.\u003c/p\u003e\n\u003cp\u003eTrial results will be published in international surgical, medical, and scientific journals, and presented at national and international conferences. The investigators will adhere to the rules and guidelines of the International Committee for Medical Journal Editors (ICMJE) when sharing the entirety of the final trial dataset.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur innovative study focuses on the use of free perforator fat flaps to wrap the brachial plexus following neurolysis in cases of recurrent neurogenic thoracic outlet syndrome (R-NTOS). We emphasize the importance of preserving donor site integrity while minimizing local dissection to prevent exacerbating fibrosis. Moreover, our wrapping technique has demonstrated effectiveness in reducing the recurrence of postoperative fibrosis [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. The study employs validated, standardized, and recommended methods for evaluating neuropathic pain, taking into account its psychosocial impact.\u003c/p\u003e \u003cp\u003eHowever, it is crucial to note that this approach necessitates extended operative time and the expertise of a double surgical team with precise microsurgical skills. Furthermore, the availability of suitable recipient vessels becomes critical following certain decompression procedures, such as resection of the thyrocervical trunk or cervical transverse.\u003c/p\u003e \u003cp\u003eOur primary objective is to assess the impact on pain of wrapping the brachial plexus with a free perforator fat flap after neurolysis in the context of neurogenic thoracic outlet syndrome (NTOS), from baseline (Day \u0026minus;\u0026thinsp;1) to six months post-surgery. This six-month period is essential for evaluating postoperative outcomes thoroughly. We would like to highlight that alternative interventions using pedicled flaps (e.g., latissimus dorsi, omentum[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] or deltopectoral flaps [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]) pose significant drawbacks such as functional impairment, abdominal incision, or concerns regarding thoracic aesthetics.\u003c/p\u003e \u003cp\u003eIn conclusion, this study serves as a pilot phase intended to pave the way for a larger randomized trial to validate our findings and provide more robust recommendations for managing R-NTOS. Additionally, we aim to assess the medical-economic impact of this longer surgical procedure involving two surgical teams in the operating room, which we believe will result in fewer recurrences and associated consequences, such as work stoppage.\u003c/p\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eTrial status\u003c/h2\u003e \u003cp\u003eThis trial is still ongoing; patient inclusion is not yet complete. The updated protocol is at version 1 on 17 September 2023. The first patient was included on 18 December 2023. Recruitment by the investigating center will continue until 24 months and the study period will end on 18 May 2026.\u003c/p\u003e \u003c/div\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eAE\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eAdverse event\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eATOS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eArterial thoracic outlet syndrome\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eCNIL\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eCommission nationale de l'informatique et des libert\u0026eacute;s\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eDASH\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eDisabilities of the Arm, Shoulder, and Hand\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eFIRST\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eFree fat flap In Recurrent neurogenic thoracic outlet Syndrome pain Treatment\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eGNEDS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eGroupement Nantais d\u0026rsquo;Ethique dans le Domaine de la Sant\u0026eacute;\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eHADS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eHospital Anxiety and Depression Scale\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eICMJE\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eInternational Committee for Medical Journal Editors\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eMCS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMental component status\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eMPQ\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eMcGill pain questionnaire\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNumerical scales\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNTOS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNeurogenic thoracic outlet syndrome\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003ePCS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003ePhysical component status\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eQDSA\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eQuestionnaire de douleur de Saint-Antoine\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eQoL\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eQuality of Life\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eRNTOS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eRecurrent neurogenic thoracic outlet syndrome\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSF-12\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eShort-Form 12\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eSF-36\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eShort-Form 36\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eTOS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eThoracic outlet syndrome\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eVTOS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eVeinous thoracic outlet syndrome\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cu\u003eEthics approval and consent to participate\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eThis clinical study was submitted to and approved by the local Ethical Board of Nantes (GNEDS- Groupement Nantais d’Ethique dans le Domaine de la Santé) on October, 2nd 2023\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eClinical trial number:\u0026nbsp;\u003c/u\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e: NCT06172101 first registration 12/07/2023\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eConsent for publication\u003c/u\u003e Not applicable — no identifying images or other personal or clinical details of participants are presented here\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eConsent to Participate declaration\u0026nbsp;\u003c/u\u003e: All the patients have provided their consent.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eAvailability of data and materials\u003c/u\u003e: Data collected during the test may be processed electronically, following the requirements of CNIL (compliance with reference methodology MR004). The investigators will share the entirety of the final trial dataset\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eCompeting interests\u003c/u\u003e: There are no financial or competing interests to be declared for the investigators.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eFunding\u003c/u\u003e: This study is an academic study with no funder and sponsored by the CHU Nantes\u003c/p\u003e\n\u003cp\u003e\u003cu\u003eAuthors' contributions\u003c/u\u003e: UL and FT designed the trial, FT, GG, UL wrote the protocol, AP, UL, FT wrote the manuscript. GG, TG and PP assisted with the drafting of the manuscript. TG wrote the methodological/statistical analyses in the protocol. All authors read and approved the final manuscript\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003ePeet RM, Henriksen JD, Anderson TP, Martin GM. Thoracic-outlet syndrome: evaluation of a therapeutic exercise program. Proc Staff Meet Mayo Clin. 1956;31:281\u0026ndash;7.\u003c/li\u003e\n \u003cli\u003eIllig KA, Rodriguez-Zoppi E. How Common Is Thoracic Outlet Syndrome? Thoracic Surgery Clinics. 2021;31:11\u0026ndash;7.\u003c/li\u003e\n \u003cli\u003eThompson RW. Challenges in the Treatment of Thoracic Outlet Syndrome. Tex Heart Inst J. 2012;39:842\u0026ndash;3.\u003c/li\u003e\n \u003cli\u003eSanders RJ, Hammond SL, Rao NM. Diagnosis of thoracic outlet syndrome. Journal of Vascular Surgery. 2007;46:601\u0026ndash;4.\u003c/li\u003e\n \u003cli\u003eChang DC, Rotellini-Coltvet LA, Mukherjee D, De Leon R, Freischlag JA. Surgical intervention for thoracic outlet syndrome improves patient\u0026rsquo;s quality of life. J Vasc Surg. 2009;49:630\u0026ndash;5; discussion 635-637.\u003c/li\u003e\n \u003cli\u003eWeaver M, Lum Y. New Diagnostic and Treatment Modalities for Neurogenic Thoracic Outlet Syndrome. Diagnostics. 2017;7:28.\u003c/li\u003e\n \u003cli\u003eJammeh ML, Yang A, Abuirqeba AA, Ohman JW, Thompson RW. Reoperative Brachial Plexus Neurolysis After Previous Anatomically Complete Supraclavicular Decompression for Neurogenic Thoracic Outlet Syndrome: A 10-Year Single-Center Case Series. Operative Neurosurgery. 2022;23:125\u0026ndash;32.\u003c/li\u003e\n \u003cli\u003eAnnest SJ, Sanders RJ. Assessment and Treatment of Recurrent NTOS. In: Illig KA, Thompson RW, Freischlag JA, Donahue DM, Jordan SE, Edgelow PI, editors. Thoracic Outlet Syndrome [Internet]. London: Springer London; 2013 [cited 2023 Sep 18]. p. 281\u0026ndash;9. Available from: https://link.springer.com/10.1007/978-1-4471-4366-6_39\u003c/li\u003e\n \u003cli\u003eLee K-T, Mun G-H. A Systematic Review of Functional Donor-Site Morbidity after Latissimus Dorsi Muscle Transfer: Plastic and Reconstructive Surgery. 2014;134:303\u0026ndash;14.\u003c/li\u003e\n \u003cli\u003eBoureau F, Luu M, Doubrere JF, Gay C. [Construction of a questionnaire for the self-evaluation of pain using a list of qualifiers. Comparison with Melzack\u0026rsquo;s McGill Pain Questionnaire]. Therapie. 1984;39:119\u0026ndash;29.\u003c/li\u003e\n \u003cli\u003eMelzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975;1:277\u0026ndash;99.\u003c/li\u003e\n \u003cli\u003eWare JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992;30:473\u0026ndash;83.\u003c/li\u003e\n \u003cli\u003eLepl\u0026egrave;ge A, Ecosse E, Verdier A, Perneger TV. The French SF-36 Health Survey: translation, cultural adaptation and preliminary psychometric evaluation. J Clin Epidemiol. 1998;51:1013\u0026ndash;23.\u003c/li\u003e\n \u003cli\u003eDubert T, Voche P, Dumontier C, Dinh A. Le questionnaire DASH. Adaptation fran\u0026ccedil;aise d\u0026rsquo;un outil d\u0026rsquo;\u0026eacute;valuation international. Chirurgie de la Main. 2001;20:294\u0026ndash;302.\u003c/li\u003e\n \u003cli\u003eZigmond AS, Snaith RP. The Hospital Anxiety and Depression Scale. Acta Psychiatr Scand. 1983;67:361\u0026ndash;70.\u003c/li\u003e\n \u003cli\u003eNovak CB, Katz J. Neuropathic Pain in Patients with Upper-Extremity Nerve Injury. Physiotherapy Canada. 2010;62:190\u0026ndash;201.\u003c/li\u003e\n \u003cli\u003eElliot D, Lloyd M, Hazari A, Sauerland S, Anand P. Relief of the pain of neuromas-in-continuity and scarred median and ulnar nerves in the distal forearm and wrist by neurolysis, wrapping in vascularized forearm fascial flaps and adjunctive procedures. J Hand Surg Eur Vol. 2010;35:575\u0026ndash;82.\u003c/li\u003e\n \u003cli\u003eBrunelli G, Brunelli F. Surgical Treatment of Actinic Brachial Plexus Lesions: Free Microvascular Transfer of the Greater Omentum. J reconstr Microsurg. 1985;1:197\u0026ndash;200.\u003c/li\u003e\n \u003cli\u003eDolan RT, Moosa A, Giele HP. The Adipofascial Deltopectoral Flap to Cover the Brachial Plexus in Thoracic Outlet Syndrome and Radiation Plexitis. Journal of Plastic, Reconstructive \u0026amp; Aesthetic Surgery. 2020;73:1465\u0026ndash;72.\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Recurrent Neurogenic Thoracic Outlet Syndrome, Pain, Brachial plexus, Free perforator flap, Neurolysis, Microsurgery.","lastPublishedDoi":"10.21203/rs.3.rs-5166504/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5166504/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground:\u003c/strong\u003e Neurogenic thoracic outlet syndrome (NTOS), characterized by brachial plexus compression, causes chronic pain and numbness in the upper extremities. Recurrences are common after surgical treatment, which typically includes an anterior scalenectomy and rib resection. Brachial plexus neurolysis and flap coverage can reduce scar fibrosis and prevent further recurrence. The latissimus dorsi flap is a common choice for this purpose. However, perforator fat flaps minimize donor site complications by avoiding muscle harvesting. Furthermore, a free flap transfer prevents new scars from developing in an already painful anatomical region. Given the lack of literature on this subject, we plan to use validated and recommended questionnaires to investigate the impact on pain and quality of life of brachial plexus wrapping with a free fat flap following neurolysis in cases of recurrent NTOS (R-NOS).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods:\u003c/strong\u003e FIRST is a single-center, prospective observational study recruiting participants over 24 months. Eligible patients over the age of 18 are treated with brachial plexus neurolysis and a free perforator fat flap for R-NTOS. The study aims to enroll 20 patients and involves preoperative and postoperative assessments at a six-month follow-up. The primary outcome, measured using numerical scales, is pain reduction. Secondary outcomes include decreased painful body surface area, maximum and average pain levels, changes in quality of life (QoL), upper limb function, and anxiety-depressive symptoms, which are measured using various validated scales and questionnaires.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion:\u003c/strong\u003e The novelty of this study lies in its ability to provide information on the impact of free perforator fat flaps in R-NTOS treatment using validated, standardized and recommended methods of assessment for neuropathic pain, particularly considering the psychosocial impact.\u003c/p\u003e","manuscriptTitle":"Free fat flap transfer in recurrent neurogenic thoracic outlet syndrome pain treatment: FIRST study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-11-11 09:56:47","doi":"10.21203/rs.3.rs-5166504/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"5fcf32db-691b-461f-be2f-c6aaf4d32338","owner":[],"postedDate":"November 11th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2024-12-05T18:08:55+00:00","versionOfRecord":[],"versionCreatedAt":"2024-11-11 09:56:47","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-5166504","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5166504","identity":"rs-5166504","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}