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Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection (NOTUBE)

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ClinicalTrials.gov Identifier: NCT00841750
Recruitment Status : Unknown
Verified July 2011 by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle.
Recruitment status was:  Recruiting
First Posted : February 11, 2009
Last Update Posted : July 20, 2011
Sponsor:
Collaborators:
Universidad Industrial de Santander
Clinica Chicamocha
Information provided by:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Lung Diseases, Interstitial Pulmonary Nodule, Solitary Procedure: Do not leave a chest tube in the pleural cavity. Procedure: Do leave a chest tube in the pleural cavity. Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The NoTube Study: Evaluation of the Necessity of a Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection.
Study Start Date : July 2008
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : June 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: No chest tube
No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
 Procedure: 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.
Active Comparator: Chest tube
Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
 Procedure: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Pneumothorax >10% / Hemothorax [ Time Frame: 1 hour and 1-5 days postoperatively ]

Secondary Outcome Measures :
  1. Pain (Visual analogue scale) [ Time Frame: At days 1-5 of hospitalization and at 1 month ]
  2. Surgical procedure duration [ Time Frame: At the end of surgery ]
  3. Hospital stay [ Time Frame: At patient discharge ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00841750


Locations
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Colombia
Fundacion Santa Fe de Bogota Recruiting
Bogota, Bogota D.C., Colombia
Contact: Luis G Garcia-Herreros, MD    (57)1 2152300 ext 1613    info@luisgarciaherrerosmd.com   
Principal Investigator: Luis G Garcia-Herreros, MD         
Clinica Chicamocha Not yet recruiting
Bucaramanga, Santander, Colombia
Contact: Carlos E Garavito, MD       cegaravito@hotmail.com   
Contact: Luis F Tapias-Vargas    76382822    ftapias@gmail.com   
Principal Investigator: Carlos E Garavito, MD         
Principal Investigator: Luis F Tapias-Vargas         
Principal Investigator: Laura I Valencia, MD         
Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle Recruiting
Floridablanca, Santander, Colombia
Contact: Leonidas Tapias, MD    76384160 ext 1717    ltapias@intercable.net.co   
Contact: Leonidas Tapias-Vargas, MD    76382822    ltapias@msn.com   
Principal Investigator: Leonidas Tapias, MD         
Principal Investigator: Leonidas Tapias-Vargas, MD         
Sponsors and Collaborators
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Universidad Industrial de Santander
Clinica Chicamocha
Investigators
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Principal Investigator: Leonidas Tapias, MD Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle
Principal Investigator: Luis C Orozco-Vargas, MD Universidad Industrial de Santander
Study Chair: Luis F Tapias-Vargas Universidad Industrial de Santander
More Information
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Responsible Party: Leonidas Tapias Diaz, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
ClinicalTrials.gov Identifier: NCT00841750    
Other Study ID Numbers: 9009001
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: July 20, 2011
Last Verified: July 2011
Keywords provided by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle:
Chest Tubes
Thoracic Surgery, Video-Assisted
Lung Diseases, Interstitial
Pulmonary Nodule, Solitary
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Lung Diseases
Lung Diseases, Interstitial
Solitary Pulmonary Nodule
Respiratory Tract Diseases
 Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms