NCT05827328已完成不适用
A Prospective Observational Study to Explore the Optimal Surgical Timing for Lung Surgery and Mediastinal Surgery After COVID-19 Infection
Shanghai Pulmonary Hospital, Shanghai, China6 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2023年1月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,000
- 试验地点
- 6
- 主要终点
- The incidence of perioperative mortality
研究概览
简要总结
Exploring the optimal interval time in patients with the clinical diagnosis of lung cancer or mediastinal tumors indicated for thoracic surgeries after SARS-CoV-2 infection by comparing 30-day mortality and 30-day morbidity.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has fully understood the nature of this study and voluntarily agreed to participate by signing an informed consent form.
- •Participants of any gender between the ages of 18 and 85 are eligible.
- •Preoperative imaging evaluation +/- biopsies indicates that the patient has resectable lung cancer or mediastinal tumors without distant metastasis.
排除标准
- •Patients who have previously undergone lung surgery;
- •Patients previously infected with SARS-CoV-2 more than 6 months before thoracic surgery;
- •Patients who did not receive Chest computed tomography (CT) at admission or within 7 days before surgery, or whose Chest CT at admission suggests pneumonia or current infection with SARS-CoV-2 (confirmed by routine laboratory tests as positive nucleic acid in admission or on the day of surgery);
- •The elapsed time from SARS-CoV-2 diagnosis to surgery is within 4 weeks;
- •Local unresectable lesions or distant metastases are found intraoperatively.
结局指标
主要结局
The incidence of perioperative mortality
时间窗: 30 days after surgery
30-day mortality after surgery
次要结局
- The incidence of perioperative complications(30 days after surgery)
研究者
Peng Zhang
Professor
Shanghai Pulmonary Hospital, Shanghai, China
研究点 (6)
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