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临床试验/NCT01575314
NCT01575314已完成不适用

Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease: A Randomized Controlled Trial

Chiang Mai University2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2011年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
53
试验地点
2
主要终点
Post-operative air leak, operative time, and duration of air leak

研究概览

简要总结

The purpose of this study is to compare the efficacy and cost difference of using a parenchymal stapling device versus hand sewing for a pulmonary lobectomy in patients with lung disease (mass or others).

详细描述

There are many lung diseases that need surgical treatment including malignancy lesion or benign lesions such as lung bleb or bullae, lung cyst, benign tumor, infection (necrotizing pneumonia, lung abscess, aspergilloma) etc. One of the most common procedure is pulmonary lobectomy. The surgical method for dividing parenchyma when performing lobectomy was divided in two methods. In the past, the investigators used hand-sewn technique but this procedure was time-consuming, high risk of air leakage, infection and re-operation, long length of hospital stay and high total cost of treatment. In the present time, the investigators use stapling device which has been used worldwide in various field of surgery since 1995. Many studies proved that using stapling devices can reduce post-operative complication, length of hospital stay and total cost of treatment and also became the standard instrument for lung surgery. In Thailand, these devices have been used for at least 5 years but they were not included in all of Health Insurance of Thai Government. Many patients had to pay for these devices by themselves, approximately 323-484.5 USD. Therefore, the investigators try to prove the hypothesis that using stapling devices for lung surgery would reduce the cost of treatment, post-operative air leakage, re-operative rate, length of hospital stay and time of surgery. The result of this study may effect the decision for including these devices in the Health Insurance of Thai Government.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who diagnosed lung diseases that need to perform pulmonary lobectomy

排除标准

  • Patients have complete fissure. therefore, no procedure need to divide the lung parenchyma.

结局指标

主要结局

Post-operative air leak, operative time, and duration of air leak

时间窗: In the operative day, after surgery, until patient can be discharged.

To compare post-operative air leakage between two groups. This data will be analyzed by fisher exact probability test. We will start observation of the air leakage at postoperative day 1. The stoping role is when statistically significant difference occur. We will measure and report in the number of patients who have post-operative air leakage.

次要结局

  • cost of treatment(within the time that patient admit in the hospital)
  • Re-operation due to postoperative air leakage(8 month after recording data)
  • Length of Hospital stay(8 month after recording data)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Apichat Tantraworasin

General thoracic surgery unit, Department of Surgery, Faculty of Medicine, Chiang Mai University Hospital

Chiang Mai University

研究点 (2)

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