Evidence map›Paper›PMID 37311694›Full record

Trial reportThe British journal of surgery2023

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 and 6 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in The British journal of surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04487561 (Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
1.4field-weighted citation impact, top 17% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04487561 nacompletednot on this map

Hemopatch Versus Axillary Drainage After Axillary Lymphadenectomy: Randomized, Controlled, Multicenter Clinical Study

TypeinterventionalSponsorFundación para la Investigación del Hospital Clínico de ValenciaRan2020 to 2023Enrolled228ConditionsBreast Cancer, Breast-conserving Surgery, Axillary Lymph Node DissectionArmshemopatch, Aspirative drainage
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 6 citations in OpenAlex.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 1 country.

Elvira Buch-VillaDepartment of Surgery, University Clinical Hospital of Valencia, Valencia, Spain.ORCID 0000-0001-7800-9935
Carlos Castañer-PugaDepartment of Surgery, University General Hospital of Valencia, Valencia, Spain.
Silvia Delgado-GarciaDepartment of Surgery, University General Hospital of Alicante, Alicante, Spain.
Carlos Fuster-DianaDepartment of Surgery, Valencian Institute of Oncology (IVO), Valencia, Spain.
Beatriz Vidal-HerradorDepartment of Surgery, University Clinical Hospital of Santiago de Compostela, A Coruña, Spain.
Francisco Ripoll-OrtsDepartment of Surgery, La Fe University and Polytechnic Hospital, Valencia, Spain.
Tania Galeote-QuecedoDepartment of Surgery, Hospital of Antequera, Málaga, Spain.
Antonio PratDepartment of Surgery, General Hospital of Requena, Valencia, Spain.
Myrian Andrés-MatiasDepartment of Surgery, Hospital of San Pedro, Logroño, Spain.
Jaime Jimeno-FraileDepartment of Surgery, University Clinical Hospital of Marques de Valdecilla, Santander, Spain.
Ernesto Muñoz-SorsonaDepartment of Surgery, University Clinical Hospital of Valencia, Valencia, Spain.
Giovani VentoDepartment of Surgery, Valencian Institute of Oncology (IVO), Valencia, Spain.
Verónica Gumbau-PucholDepartment of Surgery, University General Hospital of Valencia, Valencia, Spain.
Marcos AdrianzenDepartment of Surgery, University Clinical Hospital of Valencia, Valencia, Spain.
Vicente López-FlorDepartment of Surgery, University Clinical Hospital of Valencia, Valencia, Spain.
Joaquín OrtegaDepartment of Surgery, University Clinical Hospital of Valencia, Valencia, Spain.
Hospital Clínico Universitario de Valencia · ESFundación Instituto Valenciano de Oncología · ESHospital General Universitario De Valencia · ESHospital Arnau de Vilanova · ESHospital General Universitario de Alicante Doctor Balmis · ESHospital Regional Universitario de Málaga · ESHospital San Pedro · ESHospital Universitari i Politècnic La Fe · ESMarqués de Valdecilla University Hospital · ES

Funding

Spanish Association of Surgeons
6 · The paper itself

Abstract

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.

Indexed as

Breast NeoplasmsAxillaDrainageFemaleHospitalizationHumansLymph Node ExcisionSeroma

Identifiers

PMID37311694
PMCPMC10416686
OpenAlexW4380576885

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.