Thoracic outlet syndrome (TROTS) registry: A study protocol for the primary upper extremity deep venous thrombosis section

Ludo Schropp, Robert J.C.M.F. de Kleijn, Jan Westerink, Mathilde Nijkeuter, Evert Jan Vonken, Irene C. van der Schaaf, H. Stephan Goedee, Alexander F.J.E. Vrancken, Eline S. van Hattum, Bart Jeroen Petri, Gert J. de Borst*, Çagdas Ünlü, Remy H.H. Bemelmans, Peter E. Westerweel, Maarten Lijkwan, Anne C. Esselink, Aron S. Bode, Hinke Nagtegaal Msc, Arina ten Cate, Jorinde van LaanenArian van der Veer, Vincent van Weel, Gerben C. Mol, Jasper Florie, Daniel R. Faber, Jeroen K. de Vries, Robertus H.W. van de Mortel, Marijke Molegraaf, Vincent Jongkind, Kakkhee Yeung, Michiel Coppens, Koen E.A. van der Bogt, Edith D. Beishuizen, C. Heleen van Ommen, Marieke J.H.A. Kruip, Marie Josee E. van Rijn, Thomas van Bemmel, Peter L. Klemm, Marcel M.C. Hovens, Paul M. van Schaik, Matthijs Eefting, Anne M.E. van Well, Roos C. van Nieuwenhuizen, Sanne van Wissen, Martine C.M. Willems, Judith P. Post, Fleur S. Kleijwegt, Monique H. Suijker, TROTS registry collaborators

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Introduction There is a lack of comprehensive and uniform data on primary upper extremity deep venous thrombosis (pUEDVT). pUEDVT includes venous thoracic outlet syndrome related upper extremity deep venous thrombosis (UEDVT) and idiopathic UEDVT. Research on these conditions has been hampered by their rarity, lack of uniform diagnostic criteria, and heterogeneity in therapeutic strategies. To improve current research data collection using input of all various pUEDVT treating medical specialists, we initiated the ThoRacic OuTlet Syndrome (TROTS) registry. The aim of the TROTS registry is to a) collect extensive data on all pUEDVT patients through a predefined protocol, b) give insight in the long term outcome using patient reported outcome measures, c) create guidance in the diagnostic and clinical management of these conditions, and thereby d) help provide content for future research. Methods and analysis The TROTS registry was designed as an international prospective longitudinal observational registry for data collection on pUEDVT patients. All pUEDVT patients, regardless of treatment received, can be included in the registry after informed consent is obtained. All relevant data regarding the initial presentation, diagnostics, treatment, and follow-up will be collected prospectively in an electronic case report form. In addition, a survey containing general questions, a Health-related Quality of Life questionnaire (EQ-5D-5L), and Functional Disability questionnaire (Quick-DASH) will be sent periodically (at the time of inclusion, one and two years after inclusion, and every five years after inclusion) to the participant. The registry protocol was approved by the Medical Ethical Review Board and registered in the Netherlands Trial Register under Trial-ID NL9680. The data generated by the registry will be used for future research on pUEDVT and published in peer reviewed journals. Conclusion TROTS registry data will be used to further establish the optimal management of pUEDVT and lay the foundation for future research and guidelines.
Original languageEnglish
Article numbere0279708
Number of pages14
JournalPLOS ONE
Volume18
Issue number1
DOIs
Publication statusPublished - 6 Jan 2023

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