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

NCT ID: NCT00841750

Last Updated: 2011-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Lung Diseases, Interstitial Pulmonary Nodule, Solitary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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No chest tube

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

Group Type EXPERIMENTAL

Do not leave a chest tube in the pleural cavity.

Intervention Type 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.

Chest tube

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

Group Type ACTIVE_COMPARATOR

Do leave a chest tube in the pleural cavity.

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Industrial de Santander

OTHER

Sponsor Role collaborator

Clinica Chicamocha

UNKNOWN

Sponsor Role collaborator

Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

OTHER

Sponsor Role lead

Responsible Party

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Fundación Oftalmológica de Santander Clínica Carlos Ardila Lulle

Principal Investigators

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Leonidas Tapias, MD

Role: PRINCIPAL_INVESTIGATOR

Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle

Luis C Orozco-Vargas, MD

Role: PRINCIPAL_INVESTIGATOR

Universidad Industrial de Santander

Luis F Tapias-Vargas

Role: STUDY_CHAIR

Universidad Industrial de Santander

Locations

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Fundacion Santa Fe de Bogota

Bogotá, Bogota D.C., Colombia

Site Status RECRUITING

Clinica Chicamocha

Bucaramanga, Santander Department, Colombia

Site Status NOT_YET_RECRUITING

Fundacion Oftalmológica de Santander Clinica Carlos Ardila Lulle

Floridablanca, Santander Department, Colombia

Site Status RECRUITING

Countries

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Colombia

Facility Contacts

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Luis G Garcia-Herreros, MD

Role: primary

(57)1 2152300 ext. 1613

Carlos E Garavito, MD

Role: primary

Luis F Tapias-Vargas

Role: backup

Leonidas Tapias, MD

Role: primary

76384160 ext. 1717

Leonidas Tapias-Vargas, MD

Role: backup

Other Identifiers

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9009001

Identifier Type: -

Identifier Source: org_study_id

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