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

Phase 3

• Conditions: Lung Diseases, Interstitial; Pulmonary Nodule, Solitary

• Registration Number: NCT00841750
• Lead Sponsor: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-02-10
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20
• Primary Completion: 2012-06
• Study Completion: 2012-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pneumothorax >10% / Hemothorax	1 hour and 1-5 days postoperatively

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Fundacion Santa Fe de Bogota; 🇨🇴 Bogota, Bogota D.C., Colombia

Clinica Chicamocha; 🇨🇴 Bucaramanga, Santander, Colombia

Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle; 🇨🇴 Floridablanca, Santander, Colombia