Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Universidad Industrial de Santander | OTHER |
| Clinica Chicamocha | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No chest tube | Experimental | No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection. |
|
| Chest tube | Active Comparator | Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Do not leave a chest tube in the pleural cavity. | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumothorax >10% / Hemothorax | 1 hour and 1-5 days postoperatively |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leonidas Tapias, MD | Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle | Principal Investigator |
| Luis C Orozco-Vargas, MD | Universidad Industrial de Santander | Principal Investigator |
| Luis F Tapias-Vargas | Universidad Industrial de Santander | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Santa Fe de Bogota | Recruiting | Bogotá | Bogota D.C. | Colombia |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Do leave a chest tube in the pleural cavity. | Procedure | 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. |
|
| At patient discharge |
| Clinica Chicamocha | Not yet recruiting | Bucaramanga | Santander Department | Colombia |
|
| Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle | Recruiting | Floridablanca | Santander Department | Colombia |
|
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D003074 | Solitary Pulmonary Nodule |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided