Lung Diseases, Interstitial, Pulmonary Nodule, Solitary
Conditions
Keywords
Chest Tubes, Thoracic Surgery, Video-Assisted, Lung Diseases, Interstitial, Pulmonary Nodule, Solitary
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.
Interventions
PROCEDUREDo 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.
PROCEDUREDo 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.
Sponsors
Universidad Industrial de Santander
Clinica Chicamocha
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pneumothorax >10% / Hemothorax | 1 hour and 1-5 days postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Colombia
Outcome results
None listed