Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection (NOTUBE)
This study is currently recruiting participants.
Verified July 2011 by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Sponsor:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Collaborators:
Universidad Industrial de Santander
Clinica Chicamocha
Information provided by:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
ClinicalTrials.gov Identifier:
NCT00841750
First received: February 10, 2009
Last updated: July 19, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Diseases, Interstitial Pulmonary Nodule, Solitary |
Procedure: Do not leave a chest tube in the pleural cavity. Procedure: Do leave a chest tube in the pleural cavity. |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | The NoTube Study: Evaluation of the Necessity of a Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection. |
Resource links provided by NLM:
Further study details as provided by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle:
Primary Outcome Measures:
- Pneumothorax >10% / Hemothorax [ Time Frame: 1 hour and 1-5 days postoperatively ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pain (Visual analogue scale) [ Time Frame: At days 1-5 of hospitalization and at 1 month ] [ Designated as safety issue: No ]
- Surgical procedure duration [ Time Frame: At the end of surgery ] [ Designated as safety issue: No ]
- Hospital stay [ Time Frame: At patient discharge ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: No chest tube
No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
|
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.
|
|
Active Comparator: Chest tube
Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
|
Procedure: 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.
|
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00841750
Locations
| Colombia | |
| Fundacion Santa Fe de Bogota | Recruiting |
| Bogota, Bogota D.C., Colombia | |
| Contact: Luis G Garcia-Herreros, MD (57)1 2152300 ext 1613 info@luisgarciaherrerosmd.com | |
| Principal Investigator: Luis G Garcia-Herreros, MD | |
| Clinica Chicamocha | Not yet recruiting |
| Bucaramanga, Santander, Colombia | |
| Contact: Carlos E Garavito, MD cegaravito@hotmail.com | |
| Contact: Luis F Tapias-Vargas 76382822 ftapias@gmail.com | |
| Principal Investigator: Carlos E Garavito, MD | |
| Principal Investigator: Luis F Tapias-Vargas | |
| Principal Investigator: Laura I Valencia, MD | |
| Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle | Recruiting |
| Floridablanca, Santander, Colombia | |
| Contact: Leonidas Tapias, MD 76384160 ext 1717 ltapias@intercable.net.co | |
| Contact: Leonidas Tapias-Vargas, MD 76382822 ltapias@msn.com | |
| Principal Investigator: Leonidas Tapias, MD | |
| Principal Investigator: Leonidas Tapias-Vargas, MD | |
Sponsors and Collaborators
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Universidad Industrial de Santander
Clinica Chicamocha
Investigators
| Principal Investigator: | Leonidas Tapias, MD | Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle |
| Principal Investigator: | Luis C Orozco-Vargas, MD | Universidad Industrial de Santander |
| Study Chair: | Luis F Tapias-Vargas | Universidad Industrial de Santander |
More Information
No publications provided
| Responsible Party: | Leonidas Tapias Diaz, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle |
| ClinicalTrials.gov Identifier: | NCT00841750 History of Changes |
| Other Study ID Numbers: | 9009001 |
| Study First Received: | February 10, 2009 |
| Last Updated: | July 19, 2011 |
| Health Authority: | Colombia: Institutional Review Board |
Keywords provided by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle:
|
Chest Tubes Thoracic Surgery, Video-Assisted Lung Diseases, Interstitial Pulmonary Nodule, Solitary |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Interstitial Solitary Pulmonary Nodule Respiratory Tract Diseases Lung Neoplasms |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms |
ClinicalTrials.gov processed this record on May 19, 2013