Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Biopsies

April 4, 2016 updated by: KATZ AMIT M.D., Rambam Health Care Campus

Effectiveness and Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Resection and Biopsies ; a Prospective Randomized Controlled Study.

prospective study, involves 60 patients underwent thoracoscopic surgery, the patients will be divided into two groups, the first group will undergo early chest tube removal - after three hours, the second group will have late chest tube removal according to the department's protocol.

the study aims to prove the possibility and non inferiority for early chest tube removal for thoracoscopic surgeries with non complicated surgical course.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Presence of chest tube post thoracoscopic surgery is associated with increased morbidities like wound infection, pain, and prolong the hospital admission Corse, in the other hand, early chest tube removal is associated with increased the need for recurrent active intervention like pleural tapping for re-accumulated pleural effusion.

Method: randomized prospective study includes 60 patients who underwent thoracoscopic lobectomy/segmentectomy/ thoracoscopic mediastinal biopsy.

The study will exclude patients with difficult operative course ( intraoperative finding of significant adhesions/ intraoperative injury of the lung parenchyma/ intraoperative bleeding/failure of extubation ) and patient with post operative findings of ( bleeding in the chest tube more than 100 ml in the first hour, persistent air leak, non expanded lung on chest x-ray ) The patients will be divided into two groups, the first group - 30 patients - will undergo chest tube removal after three hours, and the second group will undergo chest tube removal according to the treating department protocol.

All patients will be evaluated regarding the pain level - subjective and objective -, admission period, infection, and the need for invasive intervention.

The patients will be evaluated during the admission, after one week and after two weeks.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient's who undergo thoracoscopic lung resection ( lobectomy or segmentectomy ), or thoracoscopic mediastinal biopsy.
  • post op there was no bleeding, the lung expanded, no persistent air leak, fluid discharge in the chest tube less than 100 ml, the patient underwent extubation.
  • patients with who read and signed informed consent regarding the participation of the study.

Exclusion Criteria:

  • Patients who underwent thoracoscopic segmental resection due to primary spontaneous pneumothorax.
  • patients who underwent thoracoscopic pleural biopsy for possible malignancy.
  • patients under 18 year old.

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: chest tube removal after 3 hours
30 patients, post thoracoscopic lobectomy, segmentectomy, thoracoscopic mediastinal biopsy, will undergo chest tube removal after 3 hours.
Procedure: Chest tube removal
chest tube removal post thoracoscopic surgery
ACTIVE_COMPARATOR: delayed chest tube removal
30 patients, post thoracoscopic lobectomy, segmentectomy, thoracoscopic mediastinal biopsy, will undergo chest tube removal according to the department's protocol, most probably post operative day 1 (POD1)
Procedure: Chest tube removal
chest tube removal post thoracoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non complicated early chest tube removal
Time Frame: two weeks
the patient with inclusion criteria can undergo early chest tube removal after three hours with no need for chest tube insertion, or pleural tapping for recurrent pleural effusion,
two weeks
Complicated early chest tube removal
Time Frame: two weeks
Patients who underwent early chest tube removal 3 hours after surgery are more liable for reinsertion of chest tube or active pleural tapping.
two weeks

Collaborators and Investigators

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

Sponsor

Rambam Health Care Campus

Investigators

  • Study Director: Ran Kremer, MD, Rambam Health Care Campus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (ESTIMATE)

April 4, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 6, 2016

Last Update Submitted That Met QC Criteria

April 4, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0361-15rmb

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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