Safety And Recovery Of Tubeless Strategy In Uniportal VATS Wedge Resection

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Pleural Re-intervention Within 30 Days [Срок оценки: From surgery to 30 days postoperatively]

Вторичные конечные точки (2)

• Lung Re-expansion on Postoperative Day 1 Chest X-ray [Срок оценки: Postoperative day 1]
• Postoperative Pain (VAS) Score [Срок оценки: Postoperative day 1 and at hospital discharge, assessed up to 30 days after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of GZMU — Гуанчжоу

Публикации

• Yang Q, Lv S, Li Q, Lan L, Sun X, Feng X, Han K. Safety and feasibility study of uniportal video-assisted thoracoscopic pulmonary wedge resection without postoperative chest tube drainage: a retrospective propensity score-matched study. Interdiscip Cardiovasc Thorac Surg. 2022 Jan 1;37(6):ivad196. doi: 10.1093/icvts/ivad196. PMID 38092062
• Ueda K, Haruki T, Murakami J, Tanaka T, Hayashi M, Hamano K. No Drain After Thoracoscopic Major Lung Resection for Cancer Helps Preserve the Physical Function. Ann Thorac Surg. 2019 Aug;108(2):399-404. doi: 10.1016/j.athoracsur.2019.03.018. Epub 2019 Apr 5. PMID 30959014
• Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy3 PMID 30304509
• Yang SM, Wang ML, Hung MH, Hsu HH, Cheng YJ, Chen JS. Tubeless Uniportal Thoracoscopic Wedge Resection for Peripheral Lung Nodules. Ann Thorac Surg. 2017 Feb;103(2):462-468. doi: 10.1016/j.athoracsur.2016.09.006. Epub 2016 Nov 16. PMID 27865474

Идентификаторы

NCT: NCT07395349 · GYFYY-THOR-TUBELESS-RCT-2026-0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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