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Starting soon Not applicable

Safety And Recovery Of Tubeless Strategy In Uniportal VATS Wedge Resection

NCT07395349 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-02-28
Last updated
2026-02-09

Condition(s) studied

Pulmonary NodulePneumothoraxPostoperative Complications

Investigational drug(s) / intervention(s)

Conventional Chest Tube DrainageSingle Intraoperative Aspiration TubelessDouble Intraoperative Aspiration Tubeless

Conventional Chest Tube Drainage: After 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: After 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: After 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.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18 to 80 years 2. Scheduled to undergo uniportal video-assisted thoracoscopic (VATS) wedge resection 3. Able to tolerate general anesthesia and single-lung ventilation 4. Passed a standardized intraoperative water-seal air leak test, confirming absence of persistent air leak before chest closure 5. Able and willing to provide written informed consent 6. Able to complete postoperative assessments and 30-day follow-up Exclusion Criteria: 1. Planned anatomical lung resection (segmentectomy or lobectomy) or combined complex thoracic procedures 2. Extensive pleural adhesions, severe emphysema, bullous lung disease, or other conditions associated with high risk of air leak 3. Positive intraoperative air leak test indicating persistent air leak 4. Requirement for additional intraoperative procedures that may significantly affect pleural air leak or lung re-expansion 5. Conversion to multiport VATS or thoracotomy before randomization 6. Severe comorbidities or other conditions deemed by the investigators to make participation inappropriate 7. Inability to complete follow-up or insufficient clinical data

Primary outcome measure(s)

  • Pleural Re-intervention Within 30 Days — From surgery to 30 days postoperatively
    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.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of GZMU Guangzhou China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07395349 on ClinicalTrials.gov ↗ ← All trials in China