Silastic Versus Conventional Drain for Postoperative Drainage in Thoracic Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Duration of hospital stay
研究概览
简要总结
In thoracic surgery, it is usual to place apical and basal drains for complete drainage of air and fluid out of the pleural cavity. The routinely used drains are mainly made of plastic. Recently silastic drains of smaller size are used without any complication. The investigators designed a prospective randomized trial to compare the draining properties of the two types of drains following various resections in thoracic surgery.
详细描述
Following the Institutional Review Board permission (permission no: 2009/27) the investigators started to recruit patients for the study in June 2009. Pneumonectomy, decortication, and diaphragm plication patients were not included in this study. The patients were consecutively placed in one of the two groups. In Group I, an apical 28FR size CD, and a basal 19FR SD were placed following surgery. In Group II, the apical drain was 28FR, and the basal drain was 32FR CDs. Basal drains were removed out when daily serous fluid drainage became 200 ml or less, and the apical were removed 48-72 hours following the cessation of air leak. The patients were discharged on the day after drain removal. The data concerning gender, age, diagnosis, operation side, type of operation, amount of fluid drainage, duration of fluid and air drainage, length of hospital stay, and complications if any, were noted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Candidates of surgery willing to participate in the experimental arm of the study and signing the informed consent form.
排除标准
- •Pneumonectomy, diaphragm plication, and decortication candidates
研究组 & 干预措施
Silastic drain
Placement of 19FR silastic drain as basal drain
干预措施: Silastic vs conventional drain in thoracic surgery (Procedure)
Conventional drain
Placement of 32FR conventional drain as basal drain
干预措施: Silastic vs conventional drain in thoracic surgery (Procedure)
结局指标
主要结局
Duration of hospital stay
时间窗: 3 years
Duration of hospital stay will be noted on the study datasheet and will be measured in days.
次要结局
- Daily amount of fluid drainage(3 years)
- Duration of fluid drainage(3 years)
- Duration of air leak(3 years)
研究者
Serhat Yalcinkaya,MD
Assist. Prof. of Thoracic Surgery
T.C. Dumlupınar Üniversitesi