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

Uniportal video-assisted thoracoscopic (VATS) wedge resection is widely used for the diagnosis and treatment of peripheral pulmonary nodules. Conventional postoperative chest tube drainage is routinely applied to prevent pneumothorax, but it is associated with increased postoperative pain, delayed mobilization, and prolonged hospital stay. In recent years, tubeless strategies have been introduced in carefully selected patients to enhance recovery; however, postoperative residual pneumothorax and pleural re-intervention remain major safety concerns.

Previous retrospective studies suggest that intraoperative aspiration may improve the feasibility of tubeless VATS, but single aspiration may not completely prevent re-entry of air into the pleural space. A modified strategy using double intraoperative aspiration performed entirely before chest closure may enhance lung re-expansion and reduce postoperative pleural complications. To date, no prospective randomized controlled trial has directly compared different intraoperative aspiration-based tubeless strategies.

This study is a single-center, prospective, three-arm randomized controlled trial conducted at Guangzhou Medical University First Affiliated Hospital. Adult patients undergoing uniportal VATS wedge resection who pass a standardized intraoperative water-seal air leak test will be randomized in a 1:1:1 ratio to one of the following groups:

conventional chest tube drainage,

single intraoperative aspiration tubeless, or

double intraoperative aspiration tubeless.

All aspiration procedures are completed intraoperatively, and no postoperative aspiration or intermittent drainage is permitted in tubeless groups. Perioperative management is standardized across all groups.

The primary outcome is the incidence of pleural re-intervention (thoracentesis or chest tube insertion) within 30 days after surgery. Secondary outcomes include postoperative recovery quality assessed by the QoR-15 questionnaire, postoperative pain assessed by visual analog scale (VAS), lung re-expansion on postoperative day 1 imaging, length of hospital stay, and postoperative pulmonary complications.

This trial aims to provide high-quality evidence to determine whether optimization of intraoperative pleural space management can improve the safety and reliability of tubeless uniportal VATS wedge resection while preserving enhanced recovery benefits.

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

De-identified individual participant data (IPD) underlying the primary and secondary outcome results, including baseline characteristics, intervention assignment, and outcome measures, will be shared.

IPD and supporting information will be available after publication of the primary study results, beginning approximately 6 months after publication, and will remain available for up to 5 years.

Access to de-identified IPD and supporting information will be granted to qualified researchers upon reasonable request. Requests must include a brief research proposal and analysis plan and be approved by the study investigators. Data will be shared for academic research purposes only, without any attempt to re-identify participants. Data will be provided through secure data transfer methods.

This is an open-label surgical trial. Due to the nature of the interventions, masking of participants, care providers, and investigators is not feasible. Outcome assessments are based on objective clinical events and standardized evaluation criteria.