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The goal of this prospective randomized clinical trial is to compare the impact of the chest tube type on pain, chest drainage efficacy and early postoperative outcome following VATS lobectomy for lung cancer.
The main questions it aims to answer are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silicone (SIL) group | Experimental | For postoperative pleural space drainage a silicone coaxial drain of size French 24 (Redax Coaxial Drain, Redax S.p.A., Poggio Rusco Mantova, Italy) was used |
|
| PVC group | Active Comparator | For postoperative pleural space drainage a standard polyvinyl chloride drain of size French 24 (Argyle, Covidien, Mansfield, USA) was used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SIL drain | Device | Silicone chest tube used for pleural space drainage after VATS lobectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analgesics consumption | Amount of analgesics used first two days after the surgery was analyzed and reported in milligrams. Higher scores mean a worse outcome. | 2 days |
| Need for peroral analgesia after the chest tube removal | Need for peroral analgesia at first, second and fourth week after chest tube removal was assessed and reported as frequency in number. Higher scores mean a worse outcome. | 2 days |
| Maximal inspiratory pressure | Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal inspiratory pressure (MIP) in cmH2O. Higher scores mean a better outcome. | 2 days |
| Maximal expiratory pressure | Post-operative pain during the first two days after the surgery was analyzed by measuring the maximal expiratory pressure (MEP) in cmH2O. Higher scores mean a better outcome. | 2 days |
| Visual analogue scale | Post-operative pain during the first two days after the surgery was analyzed by using the visual analogue scale (VAS). Scale tittle was Visual Analogue Scale. Minimum value on a scale was 0 and maximum value was 10. Higher scores mean a worse outcome. | 2 days |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of chest drainage | The effectiveness of chest drainage was analyzed by assessing the duration of chest drainage in days. Higher scores mean a worse outcome. | 1 month |
| Pneumothorax rate on the day of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Greif | UMC Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40083488 | Derived | Greif B, Zgajnar J, Stupnik T. Impact of chest tube type on pain, drainage efficacy, and short-term treatment outcome following video-assisted thoracoscopic surgery lobectomy: a randomized controlled trial comparing coaxial silicone drains and standard polyvinyl chloride drains. J Thorac Dis. 2025 Feb 28;17(2):932-943. doi: 10.21037/jtd-24-1489. Epub 2025 Feb 21. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D011183 | Postoperative Complications |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| PVC drain | Device | Polyvinyl chloride chest tube used for pleural space drainage after VATS lobectomy |
|
The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome.
| First day |
| Pneumothorax rate after chest tube removal | The effectiveness of chest drainage was analyzed by assessing the rate of pneumothorax (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome. | 1 month |
| Pleural effusion rate on the day of surgery | The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray on the day of surgery. Higher scores mean a worse outcome. | First day |
| Pleural effusion rate after chest tube removal | The effectiveness of chest drainage was analyzed by assessing the rate of pleural effusion (frequency in number) on chest x-ray after removal of the drain. Higher scores mean a worse outcome. | 1 month |
| Subcutaneous emphysema rate | The effectiveness of chest drainage was analyzed by assessing the rate of clinically expressed subcutaneous emphysema (frequency in number). Higher scores mean a worse outcome. | 1 month |
| Prolonged air leak rate | The effectiveness of chest drainage was analyzed by assessing the rate of prolonged air leak over 5 days (frequency in number). Higher scores mean a worse outcome. | 1 month |
| Reintervention rate | The effectiveness of chest drainage was analyzed by assessing the rate of reintervention (thoracentesis or chest drainage) after chest tube removal (frequency in number). Higher scores mean a worse outcome. | 1 month |
| Duration of hospital stay | Early postoperative course was analyzed by assessing the duration of hospital stay (in days). Higher scores mean a worse outcome. | 1 month |
| Respiratory complication rate | Early postoperative course was analyzed by assessing the rate of respiratory complications (frequency in number). Higher scores mean a worse outcome. | 1 month |
| Readmission rate | Early postoperative course was analyzed by assessing the rate of readmission in the first month after drain removal (frequency in number). Higher scores mean a worse outcome. | 1 month |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |