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.

Fecha de publicación: 01/06/2023 Fecha Ahead of Print: 14/06/2023

Autores de IIS La Fe

Francisco Ripoll Orts

Autor

Participantes ajenos a IIS La Fe

Buch-Villa E
Castañer-Puga C
Delgado-Garcia S
Fuster-Diana C
Vidal-Herrador B
Galeote-Quecedo T
Prat A
Andrés-Matias M
Jimeno-Fraile J
Muñoz-Sorsona E
Vento G
Gumbau-Puchol V
Adrianzen M
López-Flor V
Ortega J

Abstract

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.

Datos de la publicación

ISSN/ISSNe:: 0007-1323, 1365-2168
Tipo:: Article
Páginas:: 1180-1188
DOI:: 10.1093/bjs/znad150
PubMed:: 37311694
Factor de Impacto:: 2,479 SCImago ℠
Cuartil:: Q1 SCImago ℠

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Filiaciones

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

Keywords

THROMBIN FIBRIN SEALANT; SEROMA FORMATION; RADICAL-MASTECTOMY; FOLLOW-UP; SURGERY; PREVENTION; MANAGEMENT; IMPACT; LENGTH

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