Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease
|ClinicalTrials.gov Identifier: NCT01575314|
Recruitment Status : Completed
First Posted : April 11, 2012
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Bronchus or Lung, Unspecified||Device: stapling device||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||53 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease: A Randomized Controlled Trial|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||July 2013|
Experimental: stapling device
stapling device refer to patients who were randomized to use stapler for dividing lung parenchyma.
Device: stapling device
Stapling device include GIA 80, TA 45, endo GIA 60, endo GIA 45
Other Name: stapler
No Intervention: hand sewn
hand sewn refer to patients who were randomized to use hand suturing for dividing lung parenchyma.
- Post-operative air leak, operative time, and duration of air leak [ Time Frame: 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.
- cost of treatment [ Time Frame: within the time that patient admit in the hospital ]The cost measurements for each treatment arm focused on the following: 1) direct medical cost (costs of goods and services that are directly provided by the health care system including surgical equipment, drugs and nursing care), 2) direct non-medical cost (costs of goods and services used for health care not directly provided by the heath care system such as transportation, additional meals for patient or their relatives and residence for their relatives),and 3) indirect cost (costs of health care consumption gained as a result of a health care intervention and value of production loss due to illness or treatment such as income lost from sick-leave).
- Re-operation due to postoperative air leakage [ Time Frame: 8 month after recording data ]To compare the re-operation due to air leakage between two groups. This data will be analyzed by fisher exact probability test. We will record the re-operation due to air leakage. The stopping role is when statistically significant difference occur. In general, we accepted re-operation for air leakage especially patients who have chronic lung disease (COPD), the rate of re-operation that we can accept approximately 20-30 percent We will measure and report in the number of patients who have to perform re-operation due to post-operative air leakage.
- Length of Hospital stay [ Time Frame: 8 month after recording data ]
To compare the length of hospital stay between two groups. Counting of Length of hospital stay (days) will start at 1st post-operative day until discharge. This data will be analyzed by t-test.
We will measure and report in the unit of time (days).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575314
|Department of surgery, Faculty of medicine, Chiang Mai University Hospital|
|Amphoe Meung, Chaing Mai, Thailand, 50200|
|Principal Investigator:||Apichat Tantraworasin, M.D.||Department of Surgery, Faculty of medicine, Chiang mai University|