ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively
NCT ID: NCT02829736
Last Updated: 2017-11-06
Study Results
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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UNKNOWN
NA
90 participants
INTERVENTIONAL
2016-09-30
2018-08-31
Brief Summary
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Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, better pulmonary function and similar complication profile than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Chest tube group
Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard post-operative chest tube.
Intraoperative sealing test
A standard 28 Fr chest tube is inserted through the anterior port hole and all port holes are closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test.
Standard post-operative chest tube
A regular chest tube is left in the pleura.
No chest tube group
Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.
Intraoperative sealing test
A standard 28 Fr chest tube is inserted through the anterior port hole and all port holes are closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test.
Intraoperative chest tube removal
Chest tube is removed intraoperatively.
Interventions
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Intraoperative sealing test
A standard 28 Fr chest tube is inserted through the anterior port hole and all port holes are closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test.
Standard post-operative chest tube
A regular chest tube is left in the pleura.
Intraoperative chest tube removal
Chest tube is removed intraoperatively.
Eligibility Criteria
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Inclusion Criteria
* Speaks and understands Danish
* FEV1 \>= 60% of expected
Exclusion Criteria
* Increased risk of bleeding evaluated by surgeon (high INR, anticoagulation not paused, large bleeding, etc.)
* Air leak on intraoperative sealing test
* Patients previously included in study
* Planned intraoperative frozen section with possible lobectomy
* Previously included in current study
* Planned frozen section diagnostics
* Previous ipsilateral anatomic lung resection
18 Years
ALL
No
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Bo Laksáfoss Holbek
Medical doctor
Principal Investigators
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Henrik J. Hansen, MD
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
René H. Petersen, MD
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Henrik Kehlet, DMSc
Role: STUDY_DIRECTOR
Rigshospitalet, Denmark
Bo L. Holbek, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Rigshospitalet
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Bo L. Holbek, MD
Role: primary
Henrik J. Hansen, MD
Role: backup
Other Identifiers
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H-16028354
Identifier Type: -
Identifier Source: org_study_id