About this trial
Brief Summary
The goal of this clinical trial is to evaluate the safety and recovery outcomes of different tubeless strategies in adult patients undergoing uniportal video-assisted thoracoscopic (VATS) wedge resection who are confirmed to have no persistent air leak intraoperatively.
The main questions it aims to answer are:
Does double intraoperative aspiration tubeless strategy reduce the rate of postoperative pleural re-intervention within 30 days compared with single intraoperative aspiration tubeless strategy?
Do different intraoperative pleural space management strategies affect early postoperative recovery quality and pain?
If there is a comparison group:
Researchers will compare conventional chest tube drainage, single intraoperative aspiration tubeless, and double intraoperative aspiration tubeless strategies to determine their effects on postoperative pleural re-intervention and recovery outcomes.
Participants will:
Undergo uniportal VATS wedge resection
Receive a standardized intraoperative air leak test before chest closure
Be randomly assigned intraoperatively to one of three pleural space management strategies
Complete postoperative assessments including chest imaging, pain evaluation, and recovery quality questionnaires
Be followed for 30 days after surgery for safety outcomes
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 80 years
Scheduled to undergo uniportal video-assisted thoracoscopic (VATS) wedge resection
Able to tolerate general anesthesia and single-lung ventilation
Passed a standardized intraoperative water-seal air leak test, confirming absence of persistent air leak before chest closure
Disqualifiers
Planned anatomical lung resection (segmentectomy or lobectomy) or combined complex thoracic procedures
Extensive pleural adhesions, severe emphysema, bullous lung disease, or other conditions associated with high risk of air leak
Positive intraoperative air leak test indicating persistent air leak
Requirement for additional intraoperative procedures that may significantly affect pleural air leak or lung re-expansion
Trial design
Parallel
Treatments tested in this trial
Conventional Chest Tube Drainage
Procedure/SurgeryAfter uniportal VATS wedge resection, a chest tube is routinely placed at the end of surgery for postoperative pleural drainage. Chest tube management, including water seal or suction, criteria for tube removal, and discharge standards, follows standard institutional protocols.
Single Intraoperative Aspiration Tubeless
Procedure/SurgeryAfter uniportal VATS wedge resection and confirmation of no persistent air leak using a standardized intraoperative water-seal air leak test, a single negative-pressure aspiration of the pleural space is performed intraoperatively under positive-pressure ventilation before chest closure. The aspiration catheter is completely removed intraoperatively, and no postoperative chest tube or aspiration is allowed.
Double Intraoperative Aspiration Tubeless
Procedure/SurgeryAfter uniportal VATS wedge resection and confirmation of no persistent air leak using a standardized intraoperative water-seal air leak test, two consecutive negative-pressure aspirations of the pleural space are performed intraoperatively under positive-pressure ventilation before chest closure. After the second aspiration, the catheter is completely removed. No postoperative chest tube or aspiration is permitted.
Treatment groups
Trial outcomes
Primary outcomes
Pleural Re-intervention Within 30 Days
Incidence of pleural re-intervention within 30 days after surgery, defined as thoracentesis or chest tube insertion performed for postoperative pneumothorax or residual intrapleural air.
Secondary outcomes
Lung Re-expansion on Postoperative Day 1 Chest X-ray
Residual pneumothorax / lung re-expansion status assessed on postoperative day 1 chest X-ray using a predefined grading or qualitative evaluation.
Postoperative Pain (VAS) Score
Pain intensity assessed using a Visual Analog Scale (VAS), range 0-10, where higher scores indicate more severe pain.
Sponsors and contacts
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