Pneumothorax, Postoperative Complications, Pulmonary Nodule
Conditions
Keywords
Uniportal VATS, Wedge Resection, Tubeless, Intraoperative Aspiration, Chest Tube Drainage, Enhanced Recovery After Surgery (ERAS), Lung Re-expansion
Brief 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
Detailed description
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.
Interventions
PROCEDUREConventional 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.
PROCEDURESingle 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.
PROCEDUREDouble 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.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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.
Intervention model description
Participants who meet intraoperative eligibility criteria are randomized in a 1:1:1 ratio to three parallel groups receiving different intraoperative pleural space management strategies.
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung Re-expansion on Postoperative Day 1 Chest X-ray | Postoperative day 1 | 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 | Postoperative day 1 and at hospital discharge, assessed up to 30 days after surgery | Pain intensity assessed using a Visual Analog Scale (VAS), range 0-10, where higher scores indicate more severe pain. |
Countries
China
Contacts
CONTACTYudong Zhang, MD
Outcome results
None listed