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

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ClinicalTrials.gov Identifier: NCT00841750
Recruitment Status : Unknown
Verified July 2011 by Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle.
Recruitment status was:  Recruiting
First Posted : February 11, 2009
Last Update Posted : July 20, 2011
Sponsor:
Collaborators:
Universidad Industrial de Santander
Clinica Chicamocha
Information provided by:
Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

Tracking Information
First Submitted Date  ICMJE February 10, 2009
First Posted Date  ICMJE February 11, 2009
Last Update Posted Date July 20, 2011
Study Start Date  ICMJE July 2008
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 10, 2009)
Pneumothorax >10% / Hemothorax [ Time Frame: 1 hour and 1-5 days postoperatively ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
Pneumothorax >10% / Hemothorax [ Time Frame: Immediately after surgery and at discharge ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2009)
  • Pain (Visual analogue scale) [ Time Frame: At days 1-5 of hospitalization and at 1 month ]
  • Surgical procedure duration [ Time Frame: At the end of surgery ]
  • Hospital stay [ Time Frame: At patient discharge ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2009)
  • Pain [ Time Frame: At each day of hospitalization and at 1 month ]
  • Surgical procedure duration [ Time Frame: At the end of surgery ]
  • Hospital stay [ Time Frame: At patient discharge ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection
Official Title  ICMJE The NoTube Study: Evaluation of the Necessity of a Chest Tube After a Video-assisted Thoracoscopic Surgery Pulmonary Wedge Resection.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Lung Diseases, Interstitial
  • Pulmonary Nodule, Solitary
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: No chest tube
    No chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
    Intervention: Procedure: Do not leave a chest tube in the pleural cavity.
  • Active Comparator: Chest tube
    Chest tube left in the pleural cavity at the end of a VATS pulmonary wedge resection.
    Intervention: Procedure: Do leave a chest tube in the pleural cavity.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 10, 2009)
100
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00841750
Other Study ID Numbers  ICMJE 9009001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leonidas Tapias Diaz, Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Study Sponsor  ICMJE Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Collaborators  ICMJE
  • Universidad Industrial de Santander
  • Clinica Chicamocha
Investigators  ICMJE
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
PRS Account Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP