Effects of Energy Versus Mechanical Surgical Devices on Postoperative Cough

Official title

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

Overview

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?

Interventions

• 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.
• 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.

Primary outcome measures

• PC Severity (Perioperative) [Time frame: 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]
• PC Incidence Effects on QoL (Preoperative) [Time frame: Day 1 Pre-op]

Secondary outcome measures (11)

• PC Severity (Postoperative) [Time frame: 30th and 90th day post-op]
• PC Pain (Postoperative) [Time frame: 30th and 90th day post-op]
• PC Incidence Effects on QoL (Postoperative) [Time frame: 30th and 90th day post-op]
• Cough Sensitivity Testing [Time frame: 30th and 90th day post-op]
• Incidence of Gastrointestinal Complications [Time frame: Within the 90 days post-op]
• Incidence of Other Complications [Time frame: Within the 30 days post-op]
• Total Number and Stations of Sampled Lymph Nodes [Time frame: During surgery]
• Surgery Duration [Time frame: During surgery]
• Intubation Time [Time frame: Within the 30 days post-op]
• Incidence of Re-hospitalization [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07524712 · TJ-IRB202601115 · 202510487017

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗