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Randomized Controlled Trial Comparative Study
Comparison between use of a pleural drainage system with flutter valve and a conventional water-seal drainage system after lung resection: a randomized prospective study.
- Rodrigo Caetano de Souza, Lilianne Louise Silva de Morais, Mario Claudio Ghefter, Juliana Pereira Franceschini, and PintoFernando Campos GomesFCG0000-0003-2384-2190MD, PhD. Neurosurgeon, Head of the Cerebral Hydrodynamics Group, Functional Neurosurgery Division, Institute of Psychiatry, Hospital das Clínicas, Faculty of Medicine, Universidade de São Paulo (USP), São Pa.
- MD, MSc. Thoracic surgeon, Preceptor of the Residency Program in Thoracic Surgery, Hospital do Servidor Público Estadual de São Paulo (IAMSPE) Francisco Morato Oliveira, São Paulo (SP), Brazil.
- Sao Paulo Med J. 2024 Jan 1; 142 (5): e2023224e2023224.
BackgroundThere is still a debate regarding the most appropriate pleural collector model to ensure a short hospital stay and minimum complications.ObjectivesTo study aimed to compare the time of air leak, time to drain removal, and length of hospital stay between a standard water-seal drainage system and a pleural collector system with a unidirectional flutter valve and rigid chamber.Design And SettingA randomized prospective clinical trial was conducted at a high-complexity hospital in São Paulo, Brazil.MethodsSixty-three patients who underwent open or video-assisted thoracoscopic lung wedge resection or lobectomy were randomized into two groups, according to the drainage system used: the control group (WS), which used a conventional water-seal pleural collector, and the study group (V), which used a flutter valve device (Sinapi® Model XL1000®). Variables related to the drainage system, time of air leak, time to drain removal, and time spent in hospital were compared between the groups.ResultsMost patients (63%) had lung cancer. No differences were observed between the groups in the time of air leak or time spent hospitalized. The time to drain removal was slightly shorter in the V group; however, the difference was not statistically significant. Seven patients presented with surgery-related complications: five and two in the WS and V groups, respectively.ConclusionsAir leak, time to drain removal, and time spent in the hospital were similar between the groups. The system used in the V group resulted in no adverse events and was safe.RegistrationRBR-85qq6jc (https://ensaiosclinicos.gov.br/rg/RBR-85qq6jc).
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