Preliminary Study on the Associated Mechanisms Between Surgical Instruments and Postoperative Cough
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- PC Severity (Perioperative)
研究概览
简要总结
Numerous current studies have indicated that transecting the pulmonary plexus nerve as a routine step in radical lung cancer surgery is an independent risk factor for cough hypersensitivity (CH). However, there are significant disagreements in the thoracic surgery community regarding the strategy for managing the vagus pulmonary plexus, primarily because key clinical issues remain unresolved: How do surgical procedures affect the occurrence and development of CH? And how can these procedures be improved?
A large number of published studies have only analyzed "where to cut" while neglecting the surgical issue of "how to cut". Even with a high level of evidence, the conclusions remain contradictory. This is because doctors' preferences and changes in supply conditions can influence the selection of instruments. Differences in the energy of the instruments can lead to varying degrees and scopes of vagus nerve degeneration and collateral damage to the sympathetic pulmonary plexus, while CH is regulated by both the sympathetic and parasympathetic nervous systems.
This project intends to explore the correlation between the selection of surgical instruments and the occurrence and development of postoperative CH at the clinical level, providing a reference for optimizing surgical methods and preventing and treating postoperative CH after lung surgery.
The specific research objectives are: to clarify the correlation through a randomized controlled trial, comparing the patterns and changes in the occurrence and development of postoperative CH between two groups of patients whose autonomic nerve pulmonary plexus was transected using energy-based instruments versus mechanical methods.
Optimize the surgical procedure: Based on the above results, propose a safe, effective, and feasible surgical method to reduce intraoperative damage, prevent postoperative CH, and improve patients' quality of life.
Key problems to be solved: How do surgical operations affect the occurrence and development of CH? How can improvements be made?
- Clinical issues:
① Do energy-based instruments (causing thermal damage, etc.) and mechanical transection (causing physical damage), which lead to varying degrees of vagus nerve injury and collateral sympathetic nerve damage, affect the occurrence and development of postoperative cough hypersensitivity (CH)?
② How to optimize surgical operations to reduce the incidence of postoperative CH and improve patients' quality of life? 2. Correlation mechanisms: How do different instruments and energy modes affect the pathophysiology of nerve injury, degeneration, and repair, and what are the correlation patterns and mechanisms between these and the occurrence and development of CH?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Double-blind controlled trial: The principal investigator goes through the informed consent form with the patients one day before the surgery. The results are randomly grouped and concealed using sealed opaque envelopes. During the surgery, the surgeon opened the envelope, and neither the patients nor the outcome assessors knew about the group allocation. Postoperative follow-up was completed by observers who were also unaware of the group allocation. Bedside interviews were mainly conducted during the patient's hospital stay, while telephone follow-ups or outpatient follow-ups were used to complete the questionnaires 2 to 5 weeks after the surgery.
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 scheduled to undergo elective video-assisted thoracoscopic surgery (VATS) for partial resection of the right lung and lymph node sampling between 2025 and 2026;
- •Preoperative examination shows that the maximum diameter of the pulmonary lesion is 2 cm or less (T1), with no hilar or mediastinal lymph node metastasis and no evidence of distant metastasis (M0);
- •ASA grade I-III.
排除标准
- •With a respiratory infection in the past 4 weeks, and with a history of chronic cough, chronic bronchitis, bronchiectasis, asthma, rhinitis, gastroesophageal reflux disease, or allergic rhinitis syndrome;
- •Using angiotensin-converting enzyme inhibitors (ACEI);
- •Severe heart disease;
- •Having a history of lung surgery.
研究组 & 干预措施
Energy Devices Group
During the lymph node sampling step, to expose the subcarinal lymph nodes, energy devices (ultrasonic scalpel, electrosurgical knife) will be used to sever the vagus pulmonary plexus.
干预措施: Energy Device Vagus Nerve Transection (Device)
Mechanical Transection Group
During the lymph node sampling step, to expose the subcarinal lymph nodes, mechanical sharp dissection (cutting) will be used to sever the vagus pulmonary plexus.
干预措施: Mechanical Vagus Nerve Transection (Device)
结局指标
主要结局
PC Severity (Perioperative)
时间窗: Day 1, 2, 3, 4, 5, 6, 7 Post-op
Cough Symptom Score (CSS score) is recorded on the day and night of the 7-day follow-up. The median cough symptom score is retrieved 7 days after surgery. 0 is equivalent to no cough during the day/night, while 5 is equivalent to distressing coughs most of the day (or preventing any sleep at night).
PC Pain (Perioperative)
时间窗: Day 1, 2, 3, 4, 5, 6, 7 Post-op
Visual Analog Scale (VAS score) is recorded on the day of follow-up. The median cough symptom score is retrieved on 7 days after surgery. 1 is equivalent to no impact, and 10 is equivalent to the most pain.
PC Incidence Effects on QoL (Preoperative)
时间窗: Day 1 Pre-op
The Chinese Mandarin version of the Leicester Cough Questionnaire (LCQ) will be used to compare preoperative and postoperative changes in objective cough frequency and quality of life among patients. It is a 7-point Likert scale with a minimum value of 1, indicating chronic cough impacts participant life all of the time; and a maximum value of 7, indicating chronic cough impacts participant life none of the time.
次要结局
- Intubation Time(Within the 30 days post-op)
- Incidence of Re-hospitalization(Within the 30 days post-op)
- Surgery Duration(During surgery)
- PC Severity (Postoperative)(30th and 90th day post-op)
- PC Pain (Postoperative)(30th and 90th day post-op)
- PC Incidence Effects on QoL (Postoperative)(30th and 90th day post-op)
- Cough Sensitivity Testing(30th and 90th day post-op)
- Incidence of Gastrointestinal Complications(Within the 90 days post-op)
- Incidence of Other Complications(Within the 30 days post-op)
- Total Number and Stations of Sampled Lymph Nodes(During surgery)
- Pulmonary Function Test(Pre-op, 30th day post-op, 90th day post-op, 120th day post-op, 360th day post-op)
研究者
Shu Peng
Associate Chief Physician
Tongji Hospital