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

Lung Diseases, Interstitial Clinical Trial

— NOTUBE  

Official title:

The NoTube Study: Evaluation of the Necessity of a Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00841750
• Other study ID #: 9009001
• Status: Recruiting
• Phase: Phase 3
• First received: February 10, 2009
• Last updated: July 19, 2011
• Start date: July 2008
• Est. completion date: June 2012

Study information

• Verified date: July 2011
• Source: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Interstitial
• Multiple Pulmonary Nodules
• Pulmonary Nodule, Solitary
• Solitary Pulmonary Nodule

Intervention

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.
• 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.

Locations

Country	Name	City	State
Colombia	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

Sponsors (3)

Lead Sponsor	Collaborator
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle	Clinica Chicamocha, Universidad Industrial de Santander

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pneumothorax >10% / Hemothorax		1 hour and 1-5 days postoperatively	Yes
Secondary	Pain (Visual analogue scale)		At days 1-5 of hospitalization and at 1 month	No
Secondary	Surgical procedure duration		At the end of surgery	No
Secondary	Hospital stay		At patient discharge	No