NCT07395349

Safety And Recovery Of Tubeless Strategy In Uniportal VATS Wedge Resection

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Nodule
• Pneumothorax
• Postoperative Complications

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2026-02-28
• Primary completion: 2026-08-28
• Completion: 2026-10-01
• First posted: 2026-02-09
• Last updated: 2026-02-09

Locations

1 site across 1 country: China