Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease

Chiang Mai University

Status: Completed

Conditions: Malignant Neoplasm of Bronchus or Lung, Unspecified

Treatments: Device: stapling device

Study type: Interventional

Funder types: Other

Identifiers

NCT01575314

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

Details and patient eligibility

About

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).

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 15 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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53 participants in 2 patient groups

stapling device

Experimental group

Description:

stapling device refer to patients who were randomized to use stapler for dividing lung parenchyma.

Treatment:

Device: stapling device

hand sewn

No Intervention group

Description:

hand sewn refer to patients who were randomized to use hand suturing for dividing lung parenchyma.