Chest dRain rEmoval intrAoperatively afTer thoracOscopic Wedge Resection
NCT ID: NCT05358158
Last Updated: 2024-03-20
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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COMPLETED
NA
94 participants
INTERVENTIONAL
2022-05-04
2024-03-17
Brief Summary
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Hypothesis: Participants treated without post-operative chest tube after thoracoscopic wedge resection have less pain, reduced opioid usage without increasing postoperative complications than participants treated with standard post-operative chest tube, and could possibly be discharged earlier.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Drain-free group
Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal.
Intraoperative air leak test
A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes 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 drain removal
Chest drain is removed intraoperatively.
Chest drain group
Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard postoperative chest tube.
Intraoperative air leak test
A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes 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 chest drain placement
Chest drain is left in pleura.
Interventions
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Intraoperative air leak test
A standard 28 Fr chest drain is inserted through the anterior port hole with all port holes 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 drain removal
Chest drain is removed intraoperatively.
Standard chest drain placement
Chest drain is left in pleura.
Eligibility Criteria
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Inclusion Criteria
* Patients referred for elective three port video-assisted thoracoscopic surgery wedge resection of the lung for suspected or confirmed malignant nodules.
* first second forced expiratory volume ≥60% of expected.
* No increased bleeding risk (e.g. preoperative international normalized ratio \>2, overdue discontinuation of anticoagulants according to guidelines by the Danish Society for Thrombosis and Haemostasis, known coagulopathy).
* Not scheduled for frozen section pathology of wedge resection and subsequent lobectomy.
* Able and willing to give informed consent.
Exclusion Criteria
* Increased risk of post-operative bleeding assessed perioperatively by the surgeon (e.g. intraoperative bleeding or oozing).
* Air leak during intraoperative air leak test.
18 Years
ALL
No
Sponsors
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Aarhus University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Lin Huang
Department of cardiothoracic surgery
Principal Investigators
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René H Petersen, MD, PhD
Role: STUDY_CHAIR
Rigshospitalet, Denmark
Thomas D Christensen, MD, PhD
Role: STUDY_DIRECTOR
Aarhus University Hospital
Bo L Holbek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Morten Bendixen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Jonas J Rasmussen, MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Henrik Kehlet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Henrik J Hansen, MD
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Thomas Decker Christensen
Aarhus, Aarhus N, Denmark
Rigshospitalet
Copenhagen, , Denmark
Countries
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References
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Other Identifiers
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H-21012837
Identifier Type: -
Identifier Source: org_study_id
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