Sponsor study identifier
interventional
100
1 country
3
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
February 10, 2009
Actual (reported)February 11, 2009
Actual (reported)June 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Pneumothorax >10% / Hemothorax
1 hour and 1-5 days postoperatively
Pain (Visual analogue scale)
At days 1-5 of hospitalization and at 1 month
Surgical procedure duration
At the end of surgery
Hospital stay
At patient discharge
No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
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.
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.
Fundacion Santa Fe de Bogota
Bogotá, Bogota D.C., Colombia
Clinica Chicamocha
Bucaramanga, Santander Department, Colombia
Leonidas Tapias, MD
Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle
Luis C Orozco-Vargas, MD
Universidad Industrial de Santander
Luis F Tapias-Vargas
Universidad Industrial de Santander
First Submitted
February 10, 2009
First Posted
February 11, 2009
Study Start
July 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2012
Estimated (date passed)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle
Floridablanca, Santander Department, Colombia
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2012
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 20, 2011
Record last verified: 2011-07
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Source: ClinicalTrials.gov.
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