Clinical trial NCT02727218: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Non-Neoplastic Thoracic Disorder
Lung Diseases
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Non complicated early chest tube removal
timeFrame: two weeks
measure: Complicated early chest tube removal
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Rambam Health Care Campus
name: Ran Kremer, MD
role: STUDY_DIRECTOR
References:
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