Clinical and cost outcomes of a polyethylene glycol (PEG)-coated patch versus drainage after axillary lymph node dissection in breast cancer: results from a multicentre randomized clinical trial.

Autor:	Buch-Villa E; Department of Surgery, University Clinical Hospital of Valencia, Valencia, Spain.; INCLIVA Biomedical Research Institute, Valencia, Spain., Castañer-Puga C; Department of Surgery, University General Hospital of Valencia, Valencia, Spain., Delgado-Garcia S; Department of Surgery, University General Hospital of Alicante, Alicante, Spain., Fuster-Diana C; Department of Surgery, Valencian Institute of Oncology (IVO), Valencia, Spain., Vidal-Herrador B; Department of Surgery, University Clinical Hospital of Santiago de Compostela, A Coruña, Spain., Ripoll-Orts F; Department of Surgery, La Fe University and Polytechnic Hospital, Valencia, Spain., Galeote-Quecedo T; Department of Surgery, Hospital of Antequera, Málaga, Spain., Prat A; Department of Surgery, General Hospital of Requena, Valencia, Spain., Andrés-Matias M; Department of Surgery, Hospital of San Pedro, Logroño, Spain., Jimeno-Fraile J; Department of Surgery, University Clinical Hospital of Marques de Valdecilla, Santander, Spain., Muñoz-Sorsona E; Department of Surgery, University Clinical Hospital of Valencia, Valencia, Spain.; INCLIVA Biomedical Research Institute, Valencia, Spain., Vento G; Department of Surgery, Valencian Institute of Oncology (IVO), Valencia, Spain., Gumbau-Puchol V; Department of Surgery, University General Hospital of Valencia, Valencia, Spain., Adrianzen M; Department of Surgery, University Clinical Hospital of Valencia, Valencia, Spain.; INCLIVA Biomedical Research Institute, Valencia, Spain., López-Flor V; Department of Surgery, University Clinical Hospital of Valencia, Valencia, Spain.; INCLIVA Biomedical Research Institute, Valencia, Spain., Ortega J; Department of Surgery, University Clinical Hospital of Valencia, Valencia, Spain.; INCLIVA Biomedical Research Institute, Valencia, Spain.
Jazyk:	angličtina
Zdroj:	The British journal of surgery [Br J Surg] 2023 Aug 11; Vol. 110 (9), pp. 1180-1188.
DOI:	10.1093/bjs/znad150
Abstrakt:	Background: The aim of this study was to compare the clinical outcomes between breast cancer patients who underwent axillary lymph node dissection with postoperative management using a polyethylene glycol-coated patch versus axillary drainage. The direct costs associated with both postoperative management strategies were also evaluated. Methods: This was a multicentre RCT in women with breast cancer who underwent axillary lymph node dissection (ClinicalTrials.gov identifier: NCT04487561). Patients were randomly assigned (1 : 1) to receive either drainage or a polyethylene glycol-coated patch as postoperative management. The primary endpoints were the need for an emergency department visit for any event related to the surgery and the rate of seroma development. Results: A total of 227 patients were included , 115 in the patch group (50.7 per cent) and 112 (29.4 per cent ) in the drainage group. The incidence of emergency department visits was significantly greater for patients with drainage versus a polyethylene glycol-coated patch (incidence rate difference 26.1 per cent, 95 per cent c.i. 14.5 to 37.7 per cent; P < 0.001). Conversely, the seroma rate was significantly higher in the polyethylene glycol-coated patch group (incidence rate difference 22.8 per cent, 95 per cent c.i. 6.7 to 38.9 per cent; P < 0.0055). Compared with drainage, using a polyethylene glycol-coated patch resulted in cost savings of €100.41 per patient. An incremental cost-effectiveness ratio analysis found that drainage was associated with an incremental cost-effectiveness ratio of €7594.4 for no need for hospital admission and €491.7 for no need for an emergency department visit. Conclusion: Compared with patients who received drainage after axillary lymph node dissection, the use of a polyethylene glycol-coated patch resulted in a higher rate of seroma, but a lower number of postoperative outpatient or emergency department visits and thus a reduction in overall costs. (© The Author(s) 2023. Published by Oxford University Press on behalf of BJS Society Ltd.)
Databáze:	MEDLINE
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