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
• Sponsor: Chiang Mai University
• Information provided by (Responsible Party): Apichat Tantraworasin, Chiang Mai University

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Malignant Neoplasm of Bronchus or Lung, Unspecified	Device: stapling device	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).
2. 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.
3. 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).

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 80 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Thailand

Department of surgery, Faculty of medicine, Chiang Mai University Hospital

Amphoe Meung, Chaing Mai, Thailand, 50200

Sponsors and Collaborators

Chiang Mai University

Investigators

• Principal Investigator: Apichat Tantraworasin, M.D.; Department of Surgery, Faculty of medicine, Chiang mai University

More Information

Additional Information:

Click here for more information about this study 

Publications of Results:

Moggi L, Giustozzi GM, Cagini L, Boselli C. [Surgical staplers in thoracic surgery]. G Chir. 1992 Apr;13(4):177-9. Italian.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tantraworasin A, Seateang S, Bunchungmongkol N. Staplers versus hand-sewing for pulmonary lobectomy: randomized controlled trial. Asian Cardiovasc Thorac Ann. 2014 Mar;22(3):309-14. doi: 10.1177/0218492313491754. Epub 2013 Aug 19.

• Responsible Party: Apichat Tantraworasin, General thoracic surgery unit, Department of Surgery, Faculty of Medicine, Chiang Mai University Hospital, Chiang Mai University
• ClinicalTrials.gov Identifier: NCT01575314
• Other Study ID Numbers: SUR-11-09-26A-13-X
• First Posted: April 11, 2012
• Last Update Posted: February 2, 2016
• Last Verified: February 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Apichat Tantraworasin, Chiang Mai University:

stapling device; lobectomy; cost utility

Additional relevant MeSH terms:

Neoplasms; Bronchial Neoplasms; Lung Diseases; Respiratory Tract Diseases; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Bronchial Diseases