Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTongji Hospital

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Energy Device Vagus Nerve Transection

    Device

    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.

  • Mechanical Vagus Nerve Transection

    Device

    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.

Treatment groups

248 Participants
are divided into 2 treatment groups
Group A: Energy Devices GroupExperimental treatment 1 intervention
Group B: Mechanical Transection GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PC Severity (Perioperative)

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
2

PC Pain (Perioperative)

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, 2, 3, 4, 5, 6, 7 Post-op
3

PC Incidence Effects on QoL (Preoperative)

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
Day 1 Pre-op

Secondary outcomes

1

PC Severity (Postoperative)

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
2

PC Pain (Postoperative)

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
3

PC Incidence Effects on QoL (Postoperative)

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
4

Cough Sensitivity Testing

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
30th and 90th day post-op

Other outcomes

1

Perioperative Thoracic Hemorrhage

Perioperative intravenous hemostatic drugs are used to verify that the surgical procedures of the two groups do not affect the risk of bleeding

Time frame
During surgery

Sponsors and contacts

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