Malignant Neoplasm of Bronchus or Lung, UnspecifiedNCT01575314
Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease
A study testing stapling device in people with Malignant Neoplasm of Bronchus or Lung, Unspecified, run by Chiang Mai University at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 15 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Neoplasm of Bronchus or Lung, Unspecified
- What is being tested?
- stapling device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteThailand
- Study dates
- Nov 2011to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who diagnosed lung diseases that need to perform pulmonary lobectomy
Who cannot join
- Patients have complete fissure. therefore, no procedure need to divide the lung parenchyma.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of surgery, Faculty of medicine, Chiang Mai University Hospital
Amphoe Meung, Chaing Mai, 50200
About this study
Official title: Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease: A Randomized Controlled Trial
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).
Read the 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.
- Being tested
- stapling device
- Keywords
- stapling device, lobectomy, cost utility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stapling deviceDevice
Also called stapler
Stapling device include GIA 80, TA 45, endo GIA 60, endo GIA 45
| Study group | Role | What they receive |
|---|---|---|
| stapling device | Experimental | stapling device refer to patients who were randomized to use stapler for dividing lung parenchyma. Receives: Device: stapling device |
| hand sewn | No intervention | hand sewn refer to patients who were randomized to use hand suturing for dividing lung parenchyma. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative air leak, operative time, and duration of air leak
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.
Measured: In the operative day, after surgery, until patient can be discharged.
Secondary outcomes (3)
cost of treatment
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).
Measured: within the time that patient admit in the hospital
Re-operation due to postoperative air leakage
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.
Measured: 8 month after recording data
Length of Hospital stay
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).
Measured: 8 month after recording data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2012 (estimated)
- Study startNov 2011
- Primary completionSep 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant Neoplasm of Bronchus or Lung, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Apichat Tantraworasin, Chiang Mai University
- Investigators
- Apichat Tantraworasin, M.D., Principal investigator, Department of Surgery, Faculty of medicine, Chiang mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575314
- Sponsor's protocol ID
- SUR-11-09-26A-13-X
- Status last verified
- Feb 2016
- First submitted
- 6 Apr 2012
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Moggi L, Giustozzi GM, Cagini L, Boselli C. [Surgical staplers in thoracic surgery]. G Chir. 1992 Apr;13(4):177-9. Italian.
PubMed 1637625Tantraworasin 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.
PubMed 24585907
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-consequence Analysis of Parenchymal Stapling Device Versus Hand-sewing for Pulmonary Lobectomy in Lung Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01575314
- Acronym / sponsor ID
- SUR-11-09-26A-13-X
- Keywords
- stapling device, lobectomy, cost utility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 11 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stapling device | Experimental | Device: stapling devicestapling device refer to patients who were randomized to use stapler for dividing lung parenchyma. |
| hand sewn | No intervention | –hand sewn refer to patients who were randomized to use hand suturing for dividing lung parenchyma. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who diagnosed lung diseases that need to perform pulmonary lobectomy
Key exclusion criteria (1 listed)
- Patients have complete fissure. therefore, no procedure need to divide the lung parenchyma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stapling deviceAlso: staplerStapling device include GIA 80, TA 45, endo GIA 60, endo GIA 45 | Device | stapling device |
Primary outcome
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.
3 secondary outcomes
cost of treatment
Time frame: within the time that patient admit in the hospital
Re-operation due to postoperative air leakage
Time frame: 8 month after recording data
Length of Hospital stay
Time frame: 8 month after recording data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Results publication: PubMed 1637625Moggi L, Giustozzi GM, Cagini L, Boselli C. [Surgical staplers in thoracic surgery]. G Chir. 1992 Apr;13(4):177-9. Italian.
- Derived from this study: PubMed 24585907Tantraworasin 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.
- Click here for more information about this studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Apichat Tantraworasin, M.D. principal investigator
Department of Surgery, Faculty of medicine, Chiang mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stapling device in people with Malignant Neoplasm of Bronchus or Lung, Unspecified, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative air leak, operative time, and duration of air leak (time frame: In the operative day, after surgery, until patient can be discharged.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01575314, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2016; AzTrials last refreshed its copy on 30 Oct 2026.