Clinical trial NCT00841750: Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection
Official title: The NoTube Study: Evaluation of the Necessity of a Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Lung Diseases, Interstitial
Pulmonary Nodule, Solitary
Keywords: Chest Tubes
Thoracic Surgery, Video-Assisted
Lung Diseases, Interstitial
Pulmonary Nodule, Solitary
Lead sponsor: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Sponsor class: OTHER
Collaborators: name: Universidad Industrial de Santander
name: Clinica Chicamocha
First posted: 2009-02-11
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Pneumothorax >10% / Hemothorax
timeFrame: 1 hour and 1-5 days postoperatively
Secondary outcomes:
measure: Pain (Visual analogue scale)
timeFrame: At days 1-5 of hospitalization and at 1 month
measure: Surgical procedure duration
timeFrame: At the end of surgery
measure: Hospital stay
timeFrame: At patient discharge
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Fundacion Santa Fe de Bogota
state: Bogota D.C.
city: Bucaramanga
country: Colombia
facility: Clinica Chicamocha
state: Santander
city: Floridablanca
country: Colombia
facility: Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle
state: Santander
Study officials:
affiliation: Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle
name: Leonidas Tapias, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Industrial de Santander
name: Luis C Orozco-Vargas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad Industrial de Santander
name: Luis F Tapias-Vargas
role: STUDY_CHAIR
References: