Lung Diseases, InterstitialPhase 3NOTUBENCT00841750
Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection
A Phase 3 study testing Do not leave a chest tube in the pleural cavity. and Do leave a chest tube in the pleural cavity. in people with Lung Diseases, Interstitial and Pulmonary Nodule, Solitary, run by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle at 3 sites in Colombia.
Trial summary
After performing VATS pulmonary wedge resections, a chest tube is routinely left in the pleural cavity to drain possible air leaks and fluid accumulations. Chest tubes after VATS pulmonary wedge resections are left in place a minimum of 1 day. However, this practice has no scientific foundations. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Lung Diseases, Interstitial, Pulmonary Nodule, Solitary
- What is being tested?
- Do not leave a chest tube in the pleural cavity. and Do leave a chest tube in the pleural cavity.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesColombia
- Study dates
- Jul 2008to Jun 2012
- Phase
- Phase 3
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing video-assisted thoracoscopic surgery pulmonary wedge resections at the participating institutions.
- No evidence of air leak at the end of the surgical procedure.
- No active bleeding at the end of the surgical procedure.
Who cannot join
- Pleural effusion previous to the procedure requiring drainage after it.
- Bullous or emphysematous changes in lung parenchyma.
- Patients going to positive pressure in the airways after the procedure.
Trial locations and contacts
3 sites in 1 country.
Colombia3 sites, 3 recruiting
- Recruiting
Fundacion Santa Fe de Bogota
Bogotá, Bogota D.C.
Luis G Garcia-Herreros, MD, (57)1 2152300 ext. 1613, info@luisgarciaherrerosmd.com
Luis G Garcia-Herreros, MD
- Not yet recruiting
Clinica Chicamocha
Bucaramanga, Santander Department
Carlos E Garavito, MD, cegaravito@hotmail.com
Luis F Tapias-Vargas, 76382822, ftapias@gmail.com
- Recruiting
Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle
Floridablanca, Santander Department
Leonidas Tapias, MD, 76384160 ext. 1717, ltapias@intercable.net.co
Leonidas Tapias-Vargas, MD, 76382822, ltapias@msn.com
About this study
Official title: The NoTube Study: Evaluation of the Necessity of a Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection.
After performing VATS pulmonary wedge resections, a chest tube is routinely left in the pleural cavity to drain possible air leaks and fluid accumulations. Chest tubes after VATS pulmonary wedge resections are left in place a minimum of 1 day. However, this practice has no scientific foundations. The investigators believe it is possible to avoid the placement of a chest tube after this procedure in a great amount of patients. This is a randomized controlled clinical trial with analysis blinding in which the investigators want to compare the outcomes between installing a chest tube or not after VATS pulmonary wedge resections. The investigators will include consecutively patients with interstitial lung disease or indeterminate pulmonary nodules undergoing this procedure, at the participating institutions. The investigators calculated a sample size of 50 subjects in each group using pneumothorax < 10% data from Luckraz et al and to determine a difference of hospital stay of 2 versus 1 day; DS(1.5), power = 0.9 and alpha = 0.05.
- Being tested
- Do not leave a chest tube in the pleural cavity., Do leave a chest tube in the pleural cavity.
- Keywords
- Chest Tubes, Thoracic Surgery, Video-Assisted, Lung Diseases, Interstitial, Pulmonary Nodule, Solitary
- Medical subject headings
- Lung Diseases, Interstitial, Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Do not leave a chest tube in the pleural cavity.Procedure or surgery
At the end of a VATS wedge resection, an air leak proof will take place and if no air leak is noted, the surgical incisions for thoracoscopy ports will be closed without leaving a chest tube inserted in the pleural cavity of the patient.
Do leave a chest tube in the pleural cavity.Procedure or surgery
At the end of a VATS wedge resection, a chest tube will be inserted in the pleural cavity of the patient through the inferior surgical incision for thoracoscopy port; the rest of the incisions will be closed.
| Study group | Role | What they receive |
|---|---|---|
| No chest tube | Experimental | No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection. Receives: Procedure: Do not leave a chest tube in the pleural cavity. |
| Chest tube | Active comparator | Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection. Receives: Procedure: Do leave a chest tube in the pleural cavity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumothorax >10% / Hemothorax
Measured: 1 hour and 1-5 days postoperatively
Secondary outcomes (3)
Pain (Visual analogue scale)
Measured: At days 1-5 of hospitalization and at 1 month
Surgical procedure duration
Measured: At the end of surgery
Hospital stay
Measured: At patient discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2009 (estimated)
- Study startJul 2008
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Diseases, InterstitialStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Industrial de Santander, Clinica Chicamocha
- Investigators
- Leonidas Tapias, MD, Principal investigator, Fundacion Oftalmológica de Santander Clinica Carlos Ardila LulleLuis C Orozco-Vargas, MD, Principal investigator, Universidad Industrial de SantanderLuis F Tapias-Vargas, Study chair, Universidad Industrial de Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00841750
- Sponsor's protocol ID
- 9009001
- Acronym
- NOTUBE
- Status last verified
- Jul 2011
- First submitted
- 10 Feb 2009
- Last updated
- 20 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NoTube Study: Evaluation of the Necessity of a Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection.
- ClinicalTrials.gov ID
- NCT00841750
- Acronym / sponsor ID
- NOTUBE / 9009001
- Keywords
- Chest Tubes, Thoracic Surgery, Video-Assisted, Lung Diseases, Interstitial, Pulmonary Nodule, Solitary
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundación Oftalmológica de Santander Clínica Carlos Ardila LulleUniversity, hospital or other
- Collaborators
- Universidad Industrial de Santander, Clinica Chicamocha
- Study start
- Jul 2008
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 11 Feb 2009 (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.
After performing VATS pulmonary wedge resections, a chest tube is routinely left in the pleural cavity to drain possible air leaks and fluid accumulations. Chest tubes after VATS pulmonary wedge resections are left in place a minimum of 1 day. However, this practice has no scientific foundations. The investigators believe it is possible to avoid the placement of a chest tube after this procedure in a great amount of patients. This is a randomized controlled clinical trial with analysis blinding in which the investigators want to compare the outcomes between installing a chest tube or not after VATS pulmonary wedge resections. The investigators will include consecutively patients with interstitial lung disease or indeterminate pulmonary nodules undergoing this procedure, at the participating institutions. The investigators calculated a sample size of 50 subjects in each group using pneumothorax < 10% data from Luckraz et al and to determine a difference of hospital stay of 2 versus 1 day; DS(1.5), power = 0.9 and alpha = 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No chest tube | Experimental | Procedure: Do not leave a chest tube in the pleural cavity.No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection. |
| Chest tube | Active comparator | Procedure: Do leave a chest tube in the pleural cavity.Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing video-assisted thoracoscopic surgery pulmonary wedge resections at the participating institutions.
- No evidence of air leak at the end of the surgical procedure.
- No active bleeding at the end of the surgical procedure.
Key exclusion criteria (3 listed)
- Pleural effusion previous to the procedure requiring drainage after it.
- Bullous or emphysematous changes in lung parenchyma.
- Patients going to positive pressure in the airways after the procedure.
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 |
|---|---|---|
| Do not leave a chest tube in the pleural cavity.At the end of a VATS wedge resection, an air leak proof will take place and if no air leak is noted, the surgical incisions for thoracoscopy ports will be closed without leaving a chest tube inserted in the pleural cavity of the patient. | Procedure or surgery | No chest tube |
| Do leave a chest tube in the pleural cavity.At the end of a VATS wedge resection, a chest tube will be inserted in the pleural cavity of the patient through the inferior surgical incision for thoracoscopy port; the rest of the incisions will be closed. | Procedure or surgery | Chest tube |
Primary outcome
Pneumothorax >10% / Hemothorax
Time frame: 1 hour and 1-5 days postoperatively
3 secondary outcomes
Pain (Visual analogue scale)
Time frame: At days 1-5 of hospitalization and at 1 month
Surgical procedure duration
Time frame: At the end of surgery
Hospital stay
Time frame: At patient discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2011.
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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.
Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle
Floridablanca, Colombia
Leonidas Tapias, MD principal investigator
Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle
Luis C Orozco-Vargas, MD principal investigator
Universidad Industrial de Santander
Luis F Tapias-Vargas study chair
Universidad Industrial de Santander
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Do not leave a chest tube in the pleural cavity. and Do leave a chest tube in the pleural cavity. in people with Lung Diseases, Interstitial and Pulmonary Nodule, Solitary, run by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle at 3 sites in Colombia.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Colombia. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumothorax >10% / Hemothorax (time frame: 1 hour and 1-5 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2011.