Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030, China
NCT Number: NCT07524712
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?
1. 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?
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Wuhan, Hubei, 430030, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 30th and 90th day post-op
Cough Symptom Score (CSS score) is recorded on the day and night follow-up. The median is taken on the day of the follow-up.
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).
Time frame: 30th and 90th day post-op
Visual Analog Scale (VAS score) is recorded on the day of follow-up. 1 is equivalent to no impact, and 10 is equivalent to the most pain.
Time frame: 30th and 90th day post-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.
Time frame: 30th and 90th day post-op
Evaluate the level of cough sensitivity by comparing the intensity of stimulating factors (such as concentration, dose, etc.) or the conditions of cough responses (such as frequency, onset time, etc.)
Time frame: Within the 90 days post-op
Gastrointestinal symptoms include anorexia, belching, reflux, diarrhea, and nausea
Time frame: Within the 30 days post-op
Respiratory complications such as pulmonary infection, atelectasis, pulmonary embolism, pleural effusion, postoperative respiratory failure, and the need for tracheal intubation, as well as other systemic complications including arrhythmia, intestinal obstruction, renal failure, and cerebrovascular accident
Time frame: During surgery
Verify that the surgical procedures of the two groups have no impact on the quality of lymph node sampling
Time frame: During surgery
Time frame: Within the 30 days post-op
Time frame: Within the 30 days post-op
Time frame: Pre-op, 30th day post-op, 90th day post-op, 120th day post-op, 360th day post-op
FEV1%, FEV1/FVC% (tests to evaluate the impact of vagotomy on lung function)
Time frame: During surgery
Perioperative intravenous hemostatic drugs are used to verify that the surgical procedures of the two groups do not affect the risk of bleeding
Contact information is provided by the study sponsor or research team.
Justin Nathen C Federigan
CONTACT
Shu Peng, Medical Doctor
CONTACT
Tongji Hospital
Other
Preliminary Study on the Associated Mechanisms Between Surgical Instruments and Postoperative Cough
Acronym: ENERGY-COUGH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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