Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Biopsies
Primary Purpose
Non-Neoplastic Thoracic Disorder, Lung Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chest tube removal
Sponsored by
About this trial
This is an interventional supportive care trial for Non-Neoplastic Thoracic Disorder
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
chest tube removal after 3 hours
delayed chest tube removal
Arm Description
30 patients, post thoracoscopic lobectomy, segmentectomy, thoracoscopic mediastinal biopsy, will undergo chest tube removal after 3 hours.
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)
Outcomes
Primary Outcome Measures
Non complicated early chest tube removal
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,
Complicated early chest tube removal
Patients who underwent early chest tube removal 3 hours after surgery are more liable for reinsertion of chest tube or active pleural tapping.
Secondary Outcome Measures
Full Information
NCT ID
NCT02727218
First Posted
March 29, 2016
Last Updated
April 4, 2016
Sponsor
Rambam Health Care Campus
1. Study Identification
Unique Protocol Identification Number
NCT02727218
Brief Title
Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Biopsies
Official Title
Effectiveness and Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Resection and Biopsies ; a Prospective Randomized Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rambam Health Care Campus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Neoplastic Thoracic Disorder, Lung Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chest tube removal after 3 hours
Arm Type
Experimental
Arm Description
30 patients, post thoracoscopic lobectomy, segmentectomy, thoracoscopic mediastinal biopsy, will undergo chest tube removal after 3 hours.
Arm Title
delayed chest tube removal
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Chest tube removal
Intervention Description
chest tube removal post thoracoscopic surgery
Primary Outcome Measure Information:
Title
Non complicated early chest tube removal
Description
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,
Time Frame
two weeks
Title
Complicated early chest tube removal
Description
Patients who underwent early chest tube removal 3 hours after surgery are more liable for reinsertion of chest tube or active pleural tapping.
Time Frame
two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ran Kremer, MD
Phone
00972502063189
Email
r_kremer@rambam.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Amit Katz, MD
Phone
00972502062291
Email
amit160275@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ran Kremer, MD
Organizational Affiliation
Rambam Health Care Campus
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
12643377
Citation
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Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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Results Reference
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Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Biopsies
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