NCT00841750

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2008

Typical duration for phase_3

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 20, 2011

Status Verified

July 1, 2011

Enrollment Period

3.9 years

First QC Date

February 10, 2009

Last Update Submit

July 19, 2011

Conditions

Lung Diseases, InterstitialPulmonary Nodule, Solitary

Keywords

Chest TubesThoracic Surgery, Video-AssistedLung Diseases, InterstitialPulmonary Nodule, Solitary

Outcome Measures

Primary Outcomes (1)

  • Pneumothorax >10% / Hemothorax

    1 hour and 1-5 days postoperatively

Secondary Outcomes (3)

  • Pain (Visual analogue scale)

    At days 1-5 of hospitalization and at 1 month

  • Surgical procedure duration

    At the end of surgery

  • Hospital stay

    At patient discharge

Study Arms (2)

No chest tube

EXPERIMENTAL

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.

Chest tube

ACTIVE COMPARATOR

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.

Interventions

Do not leave a chest tube in the pleural cavity.PROCEDURE

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.

No chest tube
Do leave a chest tube in the pleural cavity.PROCEDURE

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.

Chest tube

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Fundacion Santa Fe de Bogota

Bogotá, Bogota D.C., Colombia

RECRUITING

Clinica Chicamocha

Bucaramanga, Santander Department, Colombia

NOT YET RECRUITING

Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle

Floridablanca, Santander Department, Colombia

RECRUITING

MeSH Terms

Conditions

Lung Diseases, InterstitialSolitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Leonidas Tapias, MD

    Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle

    PRINCIPAL INVESTIGATOR

  • Luis C Orozco-Vargas, MD

    Universidad Industrial de Santander

    PRINCIPAL INVESTIGATOR

  • Luis F Tapias-Vargas

    Universidad Industrial de Santander

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 10, 2009

First Posted

February 11, 2009

Study Start

July 1, 2008

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 20, 2011

Record last verified: 2011-07

Locations

CO(3)