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

February 10, 2009
July 19, 2011
July 2008
June 2012   (final data collection date for primary outcome measure)
Pneumothorax >10% / Hemothorax [ Time Frame: 1 hour and 1-5 days postoperatively ] [ Designated as safety issue: Yes ]
Pneumothorax >10% / Hemothorax [ Time Frame: Immediately after surgery and at discharge ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00841750 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pain [ Time Frame: At each day 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 ]
Not Provided
Not Provided
 
Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Lung Diseases, Interstitial
  • Pulmonary Nodule, Solitary
  • 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.
  • 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.
  • Experimental: No chest tube
    No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
    Intervention: Procedure: Do not leave a chest tube in the pleural cavity.
  • Active Comparator: Chest tube
    Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
    Intervention: Procedure: Do leave a chest tube in the pleural cavity.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2012
June 2012   (final data collection date for primary outcome measure)

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.
Both
16 Years and older
No
Colombia
 
NCT00841750
9009001
Yes
Leonidas Tapias Diaz, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
  • Universidad Industrial de Santander
  • Clinica Chicamocha
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
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP