Health Technology Assessment of Pulmonary Nodules Using Non-intubated Video-assisted Thoracic Surgery Based on the Real-world Evidence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 876
- 试验地点
- 22
- 主要终点
- Postoperative hospitalization time
研究概览
简要总结
This research focuses on a Health Technology Assessment (HTA) of non-intubated video-assisted thoracic surgery (VATS) for lung nodules. Lung cancer, one of the most prevalent malignancies globally, has a high incidence and mortality rate, particularly in China. Traditional treatments like thoracotomy are highly invasive, while conventional thoracoscopic surgery can induce anesthesia-related complications. Non-intubated VATS offers a promising alternative by avoiding intubation and mechanical ventilation, thus reducing complications, anesthesia burden, and recovery time.
The study aims to comprehensively assess the clinical effectiveness, safety, and economic viability of non-intubated VATS for lung cancer treatment through systematic literature reviews, real-world evidence (RWE), and cost-effectiveness analysis. The research will also explore patient preferences using discrete choice experiments (DCE).
By evaluating this technology from a Chinese perspective, the study seeks to provide evidence-based recommendations for the broader adoption of non-intubated VATS in clinical settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Experimental Group (Non-intubated Video-assisted Thoracic Surgery)：
- •Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).
- •Aged between 18 and 75 years, regardless of gender.
- •Preoperative assessment indicates that the patient can tolerate non-intubated video-assisted thoracic surgery.
- •The patient has signed an informed consent form and voluntarily agrees to participate in the study.
- •Control Group (Intubated Video-assisted Thoracic Surgery)：
- •Patients diagnosed with pulmonary nodules or lung cancer who are scheduled for minimally invasive surgery (including wedge resection, segmentectomy, or lobectomy).
- •Aged between 18 and 75 years, regardless of gender.
- •Preoperative assessment indicates that the patient can tolerate minimally invasive surgery.
- •The patient has signed an informed consent form and voluntarily agrees to participate in the study.
排除标准
- •Patients unable to provide sufficient preoperative and postoperative follow-up data.
- •Pregnant or breastfeeding women.
- •Patients with severe cardiopulmonary dysfunction preoperatively, making them unfit for surgery.
- •Patients who have previously undergone surgery or radiotherapy in the same chest region.
- •Patients with active infections or other severe comorbidities that may affect surgical outcomes.
- •Patients with mental illness or cognitive impairment who cannot understand the study content or comply with follow-up requirements.
研究组 & 干预措施
Non-intubated Video-assisted Thoracic Surgery Group
This group will undergo non-intubated video-assisted thoracic surgery (VATS), a minimally invasive procedure that avoids the use of endotracheal intubation and mechanical ventilation. Instead, patients maintain spontaneous breathing throughout the surgery under regional anesthesia or sedation. The technique is designed to reduce anesthesia-related complications, improve recovery times, and enhance overall patient comfort compared to traditional intubated thoracic surgeries.
Intubated Thoracic Surgery Group
This group will undergo traditional intubated thoracic surgery, where patients are intubated and placed on mechanical ventilation under general anesthesia. This method is commonly used in thoracic surgeries to control the airway and ensure adequate ventilation during the procedure. However, it may be associated with a higher incidence of anesthesia-related complications, such as airway trauma and slower postoperative recovery, compared to non-intubated techniques.
结局指标
主要结局
Postoperative hospitalization time
时间窗: Measured in days from surgery completion to hospital discharge.
The secondary outcome will measure the duration of the postoperative hospital stay. This will be assessed as the number of days from the completion of surgery to the patient's discharge. The goal is to compare the efficiency of recovery between patients undergoing non-intubated video-assisted thoracic surgery (VATS) and those receiving traditional intubated thoracic surgery.
Patient-reported Outcomes
时间窗: Measured within 3 days post-surgery
The primary outcome will be assessed using two validated instruments: MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC) and the EQ-5D-5L questionnaire. The Anderson Symptom Inventory will measure symptom severity (e.g., pain, fatigue, nausea, sleep disturbance) and the impact of symptoms on daily functioning, while the EQ-5D will evaluate overall health-related quality of life, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The scores will provide insight into patients' recovery and well-being following non-intubated video-assisted thoracic surgery (VATS) compared to traditional intubated thoracic surgery.
次要结局
未报告次要终点