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

July 19, 2011 updated by: Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

The NoTube Study: Evaluation of the Necessity of a Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Bogota D.C.
      • Bogota, Bogota D.C., Colombia
        • Recruiting
        • Fundacion Santa Fe de Bogota
        • Contact:
        • Principal Investigator:
          • Luis G Garcia-Herreros, MD
    • Santander
      • Bucaramanga, Santander, Colombia
        • Not yet recruiting
        • Clinica Chicamocha
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlos E Garavito, MD
        • Principal Investigator:
          • Luis F Tapias-Vargas
        • Principal Investigator:
          • Laura I Valencia, MD
      • Floridablanca, Santander, Colombia
        • Recruiting
        • Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leonidas Tapias, MD
        • Principal Investigator:
          • Leonidas Tapias-Vargas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pneumothorax >10% / Hemothorax
Time Frame: 1 hour and 1-5 days postoperatively
1 hour and 1-5 days postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain (Visual analogue scale)
Time Frame: At days 1-5 of hospitalization and at 1 month
At days 1-5 of hospitalization and at 1 month
Surgical procedure duration
Time Frame: At the end of surgery
At the end of surgery
Hospital stay
Time Frame: At patient discharge
At patient discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

Collaborators

Universidad Industrial de Santander
Clinica Chicamocha

Investigators

  • Principal Investigator: Leonidas Tapias, MD, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
  • Principal Investigator: Luis C Orozco-Vargas, MD, Universidad Industrial de Santander
  • Study Chair: Luis F Tapias-Vargas, Universidad Industrial de Santander

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ANTICIPATED)

June 1, 2012

Study Completion (ANTICIPATED)

June 1, 2012

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (ESTIMATE)

February 11, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2011

Last Update Submitted That Met QC Criteria

July 19, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9009001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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