NCT00841750

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.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Diseases, Interstitial
• Pulmonary Nodule, Solitary

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2009-02-11
• Last updated: 2011-07-20

Locations

3 sites across 1 country: Colombia