Safety And Recovery Of Tubeless Strategy In Uniportal VATS Wedge Resection: A Single-Center, Prospective Randomized Controlled Study Based On Different Intraoperative Pleural Space Management Strategies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Pleural Re-intervention Within 30 Days
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Able and willing to provide written informed consent
- •Able to complete postoperative assessments and 30-day follow-up
排除标准
- •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
- •Conversion to multiport VATS or thoracotomy before randomization
- •Severe comorbidities or other conditions deemed by the investigators to make participation inappropriate
- •Inability to complete follow-up or insufficient clinical data
研究组 & 干预措施
Conventional Chest Tube Drainage (CTD)
Participants undergo uniportal VATS wedge resection followed by routine postoperative chest tube drainage. A chest tube is placed at the end of surgery and managed according to standard institutional protocols, including water seal or suction, criteria for tube removal, and discharge standards. This arm serves as the control group for comparison with tubeless strategies.
干预措施: Conventional Chest Tube Drainage (Procedure)
Single Intraoperative Aspiration Tubeless (SIA-Tubeless)
Participants undergo uniportal VATS wedge resection and, after passing a standardized intraoperative water-seal air leak test, receive a single intraoperative negative-pressure aspiration of the pleural space under positive-pressure ventilation before chest closure. The catheter is completely removed intraoperatively, and no postoperative chest tube or aspiration is permitted.
干预措施: Single Intraoperative Aspiration Tubeless (Procedure)
Double Intraoperative Aspiration Tubeless (DIA-Tubeless)
Participants undergo uniportal VATS wedge resection and, after passing a standardized intraoperative water-seal air leak test, receive two consecutive intraoperative negative-pressure aspirations of the pleural space under positive-pressure ventilation before chest closure. After the second aspiration, the catheter is completely removed. No postoperative chest tube or aspiration is permitted.
干预措施: Double Intraoperative Aspiration Tubeless (Procedure)
结局指标
主要结局
Pleural Re-intervention Within 30 Days
时间窗: 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.
次要结局
- Lung Re-expansion on Postoperative Day 1 Chest X-ray(Postoperative day 1)
- Postoperative Pain (VAS) Score(Postoperative day 1 and at hospital discharge, assessed up to 30 days after surgery)
研究者
Jianxing He
Professor, Department of Thoracic Surgery
The First Affiliated Hospital of Guangzhou Medical University