Clinical trial NCT01575314: Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease
Official title: Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm of Bronchus or Lung, Unspecified
Keywords: stapling device
lobectomy
cost utility
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2012-04-11
Enrollment: 53
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: Post-operative air leak, operative time, and duration of air leak
timeFrame: In the operative day, after surgery, until patient can be discharged.
Secondary outcomes:
measure: cost of treatment
timeFrame: within the time that patient admit in the hospital
measure: Re-operation due to postoperative air leakage
timeFrame: 8 month after recording data
measure: Length of Hospital stay
timeFrame: 8 month after recording data
Other outcomes:
Locations:
city: Amphoe Meung
country: Thailand
facility: Department of surgery, Faculty of medicine, Chiang Mai University Hospital
state: Chaing Mai
Study officials:
affiliation: Department of Surgery, Faculty of medicine, Chiang mai University
name: Apichat Tantraworasin, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moggi L, Giustozzi GM, Cagini L, Boselli C. [Surgical staplers in thoracic surgery]. G Chir. 1992 Apr;13(4):177-9. Italian.
citation: 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.