A Prospective Observational Study to Explore the Early Subjective Evaluation and Objective Recovery in Lung Cancer Patients Undergoing Sublobar Resection Versus Lobectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 316
- 试验地点
- 1
- 主要终点
- Electronic patient-reported outcomes
研究概览
简要总结
The trial was designed as a single-center, non-interventional, prospective observational study to explore the role of a multimodal digital device in analyzing subjective and objective recovery in lung cancer patients undergoing sublobar resection versus lobectomy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (age ≥ 18 years)
- •American Society of Anesthesiologists (ASA) grade of III or below
- •scheduled for VATS from March to December 2023
排除标准
- •age <18 years
- •inability or poor compliance to use wearable devices
- •lack of smartphone
- •incomplete digital device data during hospitalization
- •patients with lymph node or distant metastasis
研究组 & 干预措施
Sublobar Resection Group
Patients in this group underwent sublobar resection (including segmentectomy or wedge resection). The decision for patients to receive this surgical procedure was similarly based on their routine clinical assessment, disease characteristics, physician's recommendation, and informed consent. It was not a result of randomization or active intervention by the investigators. This study will prospectively observe the post-operative recovery and prognosis of these patients, comparing them to the lobectomy group.
Lobectomy Group
Patients in this group underwent standard lobectomy. The decision for patients to receive this surgical procedure was based on their routine clinical assessment, diagnosis, disease staging, physician's recommendation, and informed consent. It was not a result of randomization or active intervention by the investigators. This study will prospectively observe the post-operative recovery and prognosis of these patients.
结局指标
主要结局
Electronic patient-reported outcomes
时间窗: From 1 day prior to surgery through hospital discharge (assessed up to 15 days).
The electronic patient-reported outcomes questionnaire includes pain, cough, shortness of breath, restless sleep, fatigue, drowsiness, walking difficulties, activity limitation, and distress(0 = no symptom, 10 = most severe).
次要结局
- Number of Lymph Nodes Dissected(During the surgical procedure (from anesthesia induction until skin closure).)
- Length of Hospital Stay(From the day of surgery until the day of discharge, assessed up to 15 days.)
- Surgical Time(During the surgical procedure (from anesthesia induction until skin closure).)
研究者
Jianxing He
Professor
The First Affiliated Hospital of Guangzhou Medical University