Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-02 @ 11:07 PM
Study NCT ID:
NCT02727218
Status:
UNKNOWN
Last Update Posted:
2016-04-06
First Post:
2016-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Biopsies
Sponsor:
Rambam Health Care Campus
Organization:
Study Overview
Official Title:
Effectiveness and Safety of Early Removal of Chest Tubes After Thoracoscopic Lung Resection and Biopsies ; a Prospective Randomized Controlled Study.
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: