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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00841750
Other study ID # 9009001
Secondary ID
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


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
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