The N-LVA Study: effectiveness and cost-effectiveness of lymphaticovenous anastomosis (LVA) for patients with cancer who suffer from chronic peripheral lymphoedema - study protocol of a multicentre, randomised sham-controlled trial.

Autor:	Kleeven A; Department of Plastic and Reconstructive Surgery, Erasmus Medical Center, Rotterdam, The Netherlands a.kleeven@erasmusmc.nl.; Department of Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands., Jonis YMJ; Department of Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands.; Department of Plastic Surgery, Radboud University Medical Center, Nijmegen, The Netherlands., Tielemans H; Department of Plastic Surgery, Radboud University Medical Center, Nijmegen, The Netherlands., van Kuijk S; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre+, Maastricht, The Netherlands., Kimman M; Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Centre+, Maastricht, The Netherlands., van der Hulst R; Department of Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands., Vasilic D; Department of Plastic and Reconstructive Surgery, Erasmus Medical Center, Rotterdam, The Netherlands., Hummelink S; Department of Plastic Surgery, Radboud University Medical Center, Nijmegen, The Netherlands., Qiu SS; Department of Plastic, Reconstructive, and Hand Surgery, Maastricht University Medical Centre+, Maastricht, The Netherlands.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2024 Apr 15; Vol. 14 (4), pp. e086226. Date of Electronic Publication: 2024 Apr 15.
DOI:	10.1136/bmjopen-2024-086226
Abstrakt:	Introduction: Cancer-related lymphoedema is one of the most debilitating side-effects of cancer treatment with an overall incidence of 15.5%. Patients may suffer from a variety of symptoms, possibly resulting in a diminished health-related quality of life (HRQoL). A microsurgical technique known as lymphaticovenous anastomosis (LVA) might be a promising treatment option. The objective of this study is to evaluate whether LVA is effective and cost-effective compared with sham surgery in improving the HRQoL. Methods and Analysis: A multicentre, double-blind, randomised sham-controlled trial conducted in three university hospitals in the Netherlands. The study population comprises 110 patients over the age of 18 years with unilateral, peripheral cancer-related lymphoedema, including 70 patients with upper limb lymphoedema and 40 patients with lower limb lymphoedema. A total of 55 patients will undergo the LVA operation, while the remaining 55 will undergo sham surgery. The follow-up will be at least 24 months. Patients are encouraged to complete the follow-up by explaining the importance of the study. Furthermore, patients may benefit from regular monitoring moments for their lymphoedema. The primary outcome is the HRQoL. The secondary outcomes are the limb circumference, excess limb volume, changes in conservative therapy, postoperative complications, patency of the LVA and incremental cost-effectiveness. Ethics and Dissemination: The study was approved by the Medical Ethical Committee of Maastricht University Medical Center on 20 September 2023 (NL84169.068.23). The results will be presented at scientific conferences and published in peer-reviewed medical journals. Trial Registration Number: NCT06082349. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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