Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough (ENERGY-COUGH)

May 2, 2026 updated by: Shu Peng, Tongji Hospital

Preliminary Study on the Associated Mechanisms Between Surgical Instruments and Postoperative Cough

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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

248

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Energy Device Vagus Nerve Transection
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.
Active Comparator: 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.
Device: Mechanical Vagus Nerve Transection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PC Severity (Perioperative)
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).
Day 1, 2, 3, 4, 5, 6, 7 Post-op
PC Pain (Perioperative)
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.
Day 1, 2, 3, 4, 5, 6, 7 Post-op
PC Incidence Effects on QoL (Preoperative)
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.
Day 1 Pre-op

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PC Severity (Postoperative)
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).
30th and 90th day post-op
PC Pain (Postoperative)
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.
30th and 90th day post-op
PC Incidence Effects on QoL (Postoperative)
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.
30th and 90th day post-op
Cough Sensitivity Testing
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.)
30th and 90th day post-op
Incidence of Gastrointestinal Complications
Time Frame: Within the 90 days post-op
Gastrointestinal symptoms include anorexia, belching, reflux, diarrhea, and nausea
Within the 90 days post-op
Incidence of Other Complications
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
Within the 30 days post-op
Total Number and Stations of Sampled Lymph Nodes
Time Frame: During surgery
Verify that the surgical procedures of the two groups have no impact on the quality of lymph node sampling
During surgery
Surgery Duration
Time Frame: During surgery
During surgery
Intubation Time
Time Frame: Within the 30 days post-op
Within the 30 days post-op
Incidence of Re-hospitalization
Time Frame: Within the 30 days post-op
Within the 30 days post-op
Pulmonary Function Test
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)
Pre-op, 30th day post-op, 90th day post-op, 120th day post-op, 360th day post-op

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Thoracic Hemorrhage
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
During surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tongji Hospital

Investigators

  • Principal Investigator: Peng Shu, Department of Thoracic Surgery, Tongji Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

March 30, 2026

First Submitted That Met QC Criteria

April 5, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJ-IRB202601115
  • 202510487017 (Other Grant/Funding Number: College Students' Innovative Entrepreneurial Training Plan Program of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

In accordance with the institution's data confidentiality requirements

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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