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


N/A
15 Years
80 Years
Not Enrolling
Both
Malignant Neoplasm of Bronchus or Lung, Unspecified

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Trial Information

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.


Inclusion Criteria:



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

Exclusion Criteria:

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Apichat Tantraworasin, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Surgery, Faculty of medicine, Chiang mai University

Authority:

Thailand: Ministry of Public Health

Study ID:

SUR-11-09-26A-13-X

NCT ID:

NCT01575314

Start Date:

April 2012

Completion Date:

February 2013

Related Keywords:

  • Malignant Neoplasm of Bronchus or Lung, Unspecified
  • stapling device
  • lobectomy
  • cost utility
  • Bronchial Neoplasms
  • Neoplasms
  • Lung Diseases

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