ThOracoscopic Wedge Resection Treated With Chest Tube Removal Intraoperatively

Study Overview
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Brief Summary
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Chest tubes are used routinely although preliminary studies demonstrate the feasibility and safety of intraoperative chest drain removal. Previous studies are however either retrospective or mainly concerning benign disease. 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.

Official Title
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Pain and Reasons for Hospitalization in Patients Treated Without Post-operative Chest Tube After Thoracoscopic Wedge Resection - A Randomized Controlled Study

Conditions
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Pain, Decreased Lung Function, Delayed Discharge

Intervention / Treatment
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* Procedure: Intraoperative sealing test
* Procedure: Standard post-operative chest tube
* Procedure: Intraoperative chest tube removal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective thoracoscopic wedge resection Speaks and understands Danish FEV1 >= 60% of expected Exclusion Criteria: Increased risk of air leak evaluated by surgeon (large adhesions, bullae, emphysema, deep resection, etc.) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chest tube group<br>Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard post-operative chest tube. | Procedure: Intraoperative sealing test<br>* 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.<br>Procedure: Standard post-operative chest tube<br>* A regular chest tube is left in the pleura.<br>|
| Experimental: No chest tube group<br>Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal. | Procedure: Intraoperative sealing test<br>* 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.<br>Procedure: Intraoperative chest tube removal<br>* Chest tube is removed intraoperatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Average pain expressed as area under the curve from a numeric rank score at 1, 3, 6 and 9 hours after surgery as well as daily at 8 am and 8 pm from post-operative day 1 until discharge. | Through post-operative admission, an average of 1 day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reasons for post-operative admission | Daily evaluation of reasons for admission. | Through post-operative admission, an average of 1 day. | 
| Lung function | FEV1 measured preoperatively and on post-operative day 1 at 8 am. | Up to post-operative day 1. | 
| Reinsertion of chest tubes | Frequency of chest tube reinsertion. | Up to post-operative day 30. | 
| Pneumothorax | Size and frequency of pneumothorax on x-ray after removal of chest tube | Up to post-operative day 1. | 
| Complications | Surgical complications including mortality. | Up to post-operative day 30. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung neoplasm, lung metastasis, enhanced recovery after surgery, fast-track surgery, intraoperative chest tube removal, pain, lung function, reasons for admission