Safety And Recovery Of Tubeless Strategy In Uniportal VATS Wedge Resection

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe First Affiliated Hospital of Guangzhou Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Conventional Chest Tube Drainage

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

300 Participants
are divided into 3 treatment groups
Group A: Conventional Chest Tube Drainage (CTD)Active comparator 1 intervention
Group B: Single Intraoperative Aspiration Tubeless (SIA-Tubeless)Experimental treatment 1 intervention
Group C: Double Intraoperative Aspiration Tubeless (DIA-Tubeless)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From surgery to 30 days postoperatively

Secondary outcomes

1

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.

Time frame
Postoperative day 1
2

Postoperative Pain (VAS) Score

Pain intensity assessed using a Visual Analog Scale (VAS), range 0-10, where higher scores indicate more severe pain.

Time frame
Postoperative day 1 and at hospital discharge, assessed up to 30 days after surgery

Other outcomes

Sponsors and contacts

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