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.

IF 1.3 4区 医学 Q2 MEDICINE, GENERAL & INTERNAL Sao Paulo Medical Journal Pub Date : 2024-04-22 eCollection Date: 2024-01-01 DOI:10.1590/1516-3180.2023.0224.R1.08022024
Rodrigo Caetano de Souza, Lilianne Louise Silva de Morais, Mario Claudio Ghefter, Juliana Pereira Franceschini, Fernando Campos Gomes Pinto
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Abstract

Background: There is still a debate regarding the most appropriate pleural collector model to ensure a short hospital stay and minimum complications.

Objectives: To 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 setting: A randomized prospective clinical trial was conducted at a high-complexity hospital in São Paulo, Brazil.

Methods: Sixty-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.

Results: Most 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.

Conclusions: Air 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.

Registration: RBR-85qq6jc (https://ensaiosclinicos.gov.br/rg/RBR-85qq6jc).

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肺切除术后使用带扑动阀的胸膜引流系统与传统水封引流系统的比较:一项随机前瞻性研究。
背景:关于最合适的胸膜收集器模型,以确保缩短住院时间和减少并发症,目前仍存在争议:本研究旨在比较标准水封引流系统与带单向扑动阀和刚性腔室的胸膜收集器系统的漏气时间、引流管移除时间和住院时间:在巴西圣保罗的一家高复杂性医院进行了一项随机前瞻性临床试验:63名接受开胸或视频辅助胸腔镜肺楔形切除术或肺叶切除术的患者根据所使用的引流系统随机分为两组:对照组(WS)使用传统的水封胸膜收集器,研究组(V)使用扑动阀装置(Sinapi® XL1000®型)。两组患者的引流系统、漏气时间、移除引流管时间和住院时间等相关变量进行了比较:大多数患者(63%)患有肺癌。结果:大多数患者(63%)患有肺癌,两组患者在漏气时间和住院时间上没有差异。V组移除引流管的时间稍短,但差异无统计学意义。七名患者出现了手术相关并发症:WS 组和 V 组分别有五名和两名:结论:两组患者的漏气率、移除引流管的时间和住院时间相似。结论:两组的漏气率、移除引流管的时间和住院时间相似,V组使用的系统未发生不良事件,安全性高:RBR-85qq6jc (https://ensaiosclinicos.gov.br/rg/RBR-85qq6jc)。
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来源期刊
Sao Paulo Medical Journal
Sao Paulo Medical Journal 医学-医学:内科
CiteScore
2.20
自引率
7.10%
发文量
210
审稿时长
6-12 weeks
期刊介绍: Published bimonthly by the Associação Paulista de Medicina, the journal accepts articles in the fields of clinical health science (internal medicine, gynecology and obstetrics, mental health, surgery, pediatrics and public health). Articles will be accepted in the form of original articles (clinical trials, cohort, case-control, prevalence, incidence, accuracy and cost-effectiveness studies and systematic reviews with or without meta-analysis), narrative reviews of the literature, case reports, short communications and letters to the editor. Papers with a commercial objective will not be accepted.
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