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Randomized Controlled Trial Multicenter Study
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.
- Elvira Buch-Villa, Carlos Castañer-Puga, Silvia Delgado-Garcia, Carlos Fuster-Diana, Beatriz Vidal-Herrador, Francisco Ripoll-Orts, Tania Galeote-Quecedo, Antonio Prat, Myrian Andrés-Matias, Jaime Jimeno-Fraile, Ernesto Muñoz-Sorsona, Giovani Vento, Verónica Gumbau-Puchol, Marcos Adrianzen, Vicente López-Flor, and Joaquín Ortega.
- Department of Surgery, University Clinical Hospital of Valencia, Valencia, Spain.
- Br J Surg. 2023 Aug 11; 110 (9): 118011881180-1188.
BackgroundThe 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.MethodsThis 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.ResultsA 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.ConclusionCompared 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.
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