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Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection (NOTUBE)

Primary Purpose

Lung Diseases, Interstitial, Pulmonary Nodule, Solitary

Status
Unknown status
Phase
Phase 3
Locations
Colombia
Study Type
Interventional
Intervention
Do not leave a chest tube in the pleural cavity.
Do leave a chest tube in the pleural cavity.
Sponsored by
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Diseases, Interstitial focused on measuring Chest Tubes, Thoracic Surgery, Video-Assisted, Lung Diseases, Interstitial, Pulmonary Nodule, Solitary

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fundacion Santa Fe de BogotaRecruiting
  • Clinica Chicamocha
  • Fundacion Oftalmológica de Santander Clinica Carlos Ardila LulleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

No chest tube

Chest tube

Arm Description

No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.

Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.

Outcomes

Primary Outcome Measures

Pneumothorax >10% / Hemothorax

Secondary Outcome Measures

Pain (Visual analogue scale)
Surgical procedure duration
Hospital stay

Full Information

First Posted
February 10, 2009
Last Updated
July 19, 2011
Sponsor
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Collaborators
Universidad Industrial de Santander, Clinica Chicamocha
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1. Study Identification

Unique Protocol Identification Number
NCT00841750
Brief Title
Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection
Acronym
NOTUBE
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

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2008 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Collaborators
Universidad Industrial de Santander, Clinica Chicamocha

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Interstitial, Pulmonary Nodule, Solitary
Keywords
Chest Tubes, Thoracic Surgery, Video-Assisted, Lung Diseases, Interstitial, Pulmonary Nodule, Solitary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
No chest tube
Arm Type
Experimental
Arm Description
No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
Arm Title
Chest tube
Arm Type
Active Comparator
Arm Description
Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
Intervention Type
Procedure
Intervention Name(s)
Do not leave a chest tube in the pleural cavity.
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Do leave a chest tube in the pleural cavity.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pneumothorax >10% / Hemothorax
Time Frame
1 hour and 1-5 days postoperatively
Secondary Outcome Measure Information:
Title
Pain (Visual analogue scale)
Time Frame
At days 1-5 of hospitalization and at 1 month
Title
Surgical procedure duration
Time Frame
At the end of surgery
Title
Hospital stay
Time Frame
At patient discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonidas Tapias, MD
Organizational Affiliation
Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis C Orozco-Vargas, MD
Organizational Affiliation
Universidad Industrial de Santander
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis F Tapias-Vargas
Organizational Affiliation
Universidad Industrial de Santander
Official's Role
Study Chair
Facility Information:
Facility Name
Fundacion Santa Fe de Bogota
City
Bogota
State/Province
Bogota D.C.
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis G Garcia-Herreros, MD
Phone
(57)1 2152300
Ext
1613
Email
info@luisgarciaherrerosmd.com
First Name & Middle Initial & Last Name & Degree
Luis G Garcia-Herreros, MD
Facility Name
Clinica Chicamocha
City
Bucaramanga
State/Province
Santander
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos E Garavito, MD
Email
cegaravito@hotmail.com
First Name & Middle Initial & Last Name & Degree
Luis F Tapias-Vargas
Phone
76382822
Email
ftapias@gmail.com
First Name & Middle Initial & Last Name & Degree
Carlos E Garavito, MD
First Name & Middle Initial & Last Name & Degree
Luis F Tapias-Vargas
First Name & Middle Initial & Last Name & Degree
Laura I Valencia, MD
Facility Name
Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle
City
Floridablanca
State/Province
Santander
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leonidas Tapias, MD
Phone
76384160
Ext
1717
Email
ltapias@intercable.net.co
First Name & Middle Initial & Last Name & Degree
Leonidas Tapias-Vargas, MD
Phone
76382822
Email
ltapias@msn.com
First Name & Middle Initial & Last Name & Degree
Leonidas Tapias, MD
First Name & Middle Initial & Last Name & Degree
Leonidas Tapias-Vargas, MD

12. IPD Sharing Statement

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Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection

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