Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough

NCT07524712 | Not Yet Recruiting

• 2 other identifiers: TJ-IRB202601115202510487017
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Clinical issues:
2. 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?

Conditions

Postoperative Cough; Cough Hypersensitivity Syndrome

Keywords

postoperative cough; persistent cough; surgical instruments; cough hypersensitivity; vagus pulmonary plexus; vagus nerve

Outcome Measures

Primary Outcomes (3)

• 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).

  Day 1, 2, 3, 4, 5, 6, 7 Post-op

• 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.

  Day 1, 2, 3, 4, 5, 6, 7 Post-op

• 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.

  Day 1 Pre-op

Secondary Outcomes (11)

• 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

Other Outcomes (1)

• Perioperative Thoracic Hemorrhage

  During surgery

Study Arms (2)

Energy Devices Group

EXPERIMENTAL

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

Mechanical Transection Group

ACTIVE COMPARATOR

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

Interventions

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.

Energy Devices Group

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.

Mechanical Transection Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Related Publications (10)

• Ruan ZG, Xu CY, Hua LF. A commentary on 'Pulmonary vagus nerve transection for chronic cough after video-assisted lobectomy: a randomized controlled trial'. Int J Surg. 2024 Jul 1;110(7):4524-4525. doi: 10.1097/JS9.0000000000001428. No abstract available.

  PMID: 38597401 BACKGROUND

• Zhang Q, Ge Y, Sun T, Feng S, Zhang C, Hong T, Liu X, Han Y, Cao JL, Zhang H. Pulmonary vagus nerve transection for chronic cough after video-assisted lobectomy: a randomized controlled trial. Int J Surg. 2024 Mar 1;110(3):1556-1563. doi: 10.1097/JS9.0000000000001017.

  PMID: 38116674 BACKGROUND

• Cheng X, Chen H. Commentary on the impacts of postoperative complications on survival after lung cancer surgery. J Thorac Cardiovasc Surg. 2018 Mar;155(3):1265-1266. doi: 10.1016/j.jtcvs.2017.10.122. Epub 2017 Nov 6. No abstract available.

  PMID: 29198796 BACKGROUND

• Weijs TJ, Ruurda JP, Luyer MD, Nieuwenhuijzen GA, van Hillegersberg R, Bleys RL. Topography and extent of pulmonary vagus nerve supply with respect to transthoracic oesophagectomy. J Anat. 2015 Oct;227(4):431-9. doi: 10.1111/joa.12366.

  PMID: 26352410 BACKGROUND

• Mazzone SB, Undem BJ. Vagal Afferent Innervation of the Airways in Health and Disease. Physiol Rev. 2016 Jul;96(3):975-1024. doi: 10.1152/physrev.00039.2015.

  PMID: 27279650 BACKGROUND

• Barnes PJ. Neurogenic inflammation in the airways. Respir Physiol. 2001 Mar;125(1-2):145-54. doi: 10.1016/s0034-5687(00)00210-3.

  PMID: 11240158 BACKGROUND

• Naqvi KF, Mazzone SB, Shiloh MU. Infectious and Inflammatory Pathways to Cough. Annu Rev Physiol. 2023 Feb 10;85:71-91. doi: 10.1146/annurev-physiol-031422-092315. Epub 2022 Sep 28.

  PMID: 36170660 BACKGROUND

• Kepicova M, Tulinsky L, Konde A, Dzurnakova P, Ihnat P, Adamica D, Neoral C, Martinek L. Risk Factors and Postoperative Complications of Lobectomy for Non-Small Cell Lung Cancer: An Exploratory Analysis of Premedication and Clinical Variables. Medicina (Kaunas). 2024 Dec 20;60(12):2088. doi: 10.3390/medicina60122088.

  PMID: 39768967 BACKGROUND

• Polverino M, Polverino F, Fasolino M, Ando F, Alfieri A, De Blasio F. Anatomy and neuro-pathophysiology of the cough reflex arc. Multidiscip Respir Med. 2012 Jun 18;7(1):5. doi: 10.1186/2049-6958-7-5.

  PMID: 22958367 BACKGROUND

• Sun X, Lan Z, Li S, Huang S, Zeng C, Wu J, Chen Q, Chen Y, Chen Z, Tang Y, Qiao G. Trajectories and risk factors of persistent cough after pulmonary resection: A prospective two-center study. Thorac Cancer. 2023 Dec;14(36):3503-3510. doi: 10.1111/1759-7714.15147. Epub 2023 Nov 3.

  PMID: 37920959 BACKGROUND

MeSH Terms

Conditions

cough hypersensitivity syndrome; Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Shu Peng, Medical Doctor

CONTACT

+86 18571716422; drpeng90@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Model Details: Lymph nodes are grouped according to the standards of the American Joint Committee on Cancer (AJCC) and sampled in accordance with the NCCN Non-Small Cell Lung Cancer Guidelines (2025). In the right thoracic cavity (groups 4, 7, 9, 10, 11), 2 groups of N1 lymph nodes and 2 groups of N2 lymph nodes are sampled. The posterior mediastinal pleura is opened parallel to the main trunk of the vagus nerve, and the distance between the instrument and the main trunk of the vagus nerve is recorded. 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 in Group A; while mechanical sharp dissection (cutting) will be used to sever the same plexus in Group B.

Study Record Dates

• First Submitted: March 30, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)