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.

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.

Chest wall reconstruction after the Clagett procedure and other types of open-window thoracostomy: a narrative review.

Background and Objective: The Clagett procedure is one of the last treatment options for chronic stage pleural empyema. It involves the formation of an open-window in the thoracic wall to allow for continuous drainage and irrigation of the pleural cavity. Once the empyema has been resolved, reconstruction of the chest wall is sometimes challenging. This review aims to identify and summarize the options for reconstructing soft tissue defects of the chest wall following the Clagett procedure and other types of open-window thoracostomy. Methods: A narrative review was performed of the literature on PubMed, Cochrane Library, ClinicalTrials.gov, and Google Scholar, including all relevant studies published until January 2023. Key Content and Findings: This review contains an overview of the reconstruction methods and the outcomes of the included studies on reconstructive options after the Clagett procedure and other types of open-window thoracostomy. A subdivision was made based on reconstruction type: pedicled flaps, free flaps, and the use of a vacuum-assisted closure (VAC) device. The advantages of pedicled flaps are reliable vascularization, better tissue match, reduced scarring, and shorter operation time compared to free flaps. However, when pedicled flaps are not available due to damage during previous surgeries or offer insufficient volume to obliterate the cavity, free flaps might be a solution. Conclusions: In cases where an open-window thoracostomy necessitates chest wall reconstruction, a pedicled flap is the preferred choice, followed by free flaps. Additionally, vacuum-assisted negative pressure wound therapy (VANPWT) techniques have shown potentially promising results (as an adjunct to surgical treatment).