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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Universidad Industrial de Santander
Clinica Chicamocha
Information provided by:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
ClinicalTrials.gov Identifier:
NCT00841750
First received: February 10, 2009
Last updated: July 19, 2011
Last verified: July 2011
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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.

Resource links provided by NLM:


Further study details as provided by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle:

Primary Outcome Measures:
  • Pneumothorax >10% / Hemothorax [ Time Frame: 1 hour and 1-5 days postoperatively ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pain (Visual analogue scale) [ Time Frame: At days 1-5 of hospitalization and at 1 month ] [ Designated as safety issue: No ]
  • Surgical procedure duration [ Time Frame: At the end of surgery ] [ Designated as safety issue: No ]
  • Hospital stay [ Time Frame: At patient discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2008
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841750

Locations
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
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

No publications provided

Responsible Party: Leonidas Tapias Diaz, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
ClinicalTrials.gov Identifier: NCT00841750     History of Changes
Other Study ID Numbers: 9009001
Study First Received: February 10, 2009
Last Updated: July 19, 2011
Health Authority: Colombia: Institutional Review Board

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:
Lung Diseases
Lung Diseases, Interstitial
Multiple Pulmonary Nodules
Solitary Pulmonary Nodule
Lung Neoplasms
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014