Coaxial Drainage Versus Standard Chest Tube After Pulmonary Lobectomy: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Daily fluid drainage (mL)
研究概览
简要总结
Objectives: Chest tubes are routinely inserted after thoracic surgery procedures in different size and numbers. The aim of this study is to assess the efficacy of Smart Drain Coaxial drainage compared with two standard chest tubes in patients undergoing thoracotomy for pulmonary lobectomy. 98 patients (57 males and 41 females, mean age 68.3±7.4 years) with lung cancer undergoing open pulmonary lobectomy were randomized in two groups: 50 received one upper 28-Fr and one lower 32-Fr standard chest tube (ST group) and 48 received one 28-Fr Smart Drain Coaxial tube (CT group). Hospitalization data, quantity of fluid output, air leaks, radiograph findings, pain control and costs were assessed.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age more than 18 years
- •patients scheduled for pulmonary lobectomy
排除标准
- •middle lobectomy,
- •extended resections, minimally invasive lobectomies,
- •previous ipsilateral thoracic surgery,
- •induction chemo and/or radiotherapy
- •patients who did not give consent to participate.
结局指标
主要结局
Daily fluid drainage (mL)
时间窗: 1 postoperative day
Quality of fluid drainage evaluated in mL and by means of a chest X rays
Presence of postoperative pneumothorax
时间窗: 1 postoperative day
Quality of air drainage evaluated by chest X rays
次要结局
- presence of pneumothorax after tubes removal(within 24 hours after tubes removal)
- evaluation of pain measured by Visual Analogue Scale(1 postoperative day)
- Analysis of costs (in euros)(until discharge, an average of 6 days)
- Postoperative hospitalization (in days)(until discharge, an average of 6 days)
研究者
Marco Anile
Principal Investigator
University of Roma La Sapienza