Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease: A Randomized Controlled Trial
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Post-operative air leak, operative time, and duration of air leak
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.
In the operative day, after surgery, until patient can be discharged.
Apichat Tantraworasin, M.D.
Department of Surgery, Faculty of medicine, Chiang mai University
Thailand: Ministry of Public Health