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Slow accrual
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chest tube group | Active Comparator | Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with a standard post-operative chest tube. |
|
| No chest tube group | Experimental | Participants undergoing video-assisted thoracoscopic wedge resection with a positive intraoperative sealing test are treated with intraoperative chest tube removal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative sealing test | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on NRS | Differences in pain between the two groups. | Through post-operative admission, an average of 1 day. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik J. Hansen, MD | Rigshospitalet, Denmark | Study Director |
| René H. Petersen, MD | Rigshospitalet, Denmark | Study Director |
| Henrik Kehlet, DMSc | Rigshospitalet, Denmark | Study Director |
| Bo L. Holbek, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D012131 | Respiratory Insufficiency |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
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Randomization occurs after ended surgery, thus masking allocation to the personnel and participant. After Randomization, there is no masking.
|
| Standard post-operative chest tube | Procedure | A regular chest tube is left in the pleura. |
|
| Intraoperative chest tube removal | Procedure | Chest tube is removed intraoperatively. |
|
| 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. |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |