Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy

NCT04247997 | Completed

• 1 other identifier: XYFY2019-KL179-01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to determine whether disconnecting pulmonary vagus nerve branch can abatement chronic cough in patients undergoing unilateral thoracoscopic lobectomy,compared with preserving pulmonary vagus nerve branch.

Conditions

Postoperative Chronic Cough

Keywords

postoperative chronic cough; pulmonary vagus nerve branch; autonomic nervous system; pulmonary nerves; thoracoscopic lobectomy

Outcome Measures

Primary Outcomes (1)

• The incidence of chronic cough after surgery

  More than 8 weeks after surgery, there is no clear cause of cough with stable chest CT excluding the diagnosis of postnasal drip syndrome, asthma or the use of Angiotensin-converting enzyme inhibitor(ACEI), etc.

  3 months after surgery

Secondary Outcomes (12)

• The incidence of chronic cough after surgery

  1 month after surgery

• The score of the LCQ-MC scale after surgery

  1 month and 3 months after surgery

• Length of operation

  during the operation

• volume of bleeding

  during the operation

• volume of postoperative drainage

  within 30 days after surgery

Study Arms (2)

Group D

EXPERIMENTAL

disconnect pulmonary vague nerve branches

Procedure: disconnect pulmonary vague nerve branches

Group P

NO INTERVENTION

preserve the pulmonary vague nerve branches

Interventions

disconnect pulmonary vague nerve branches PROCEDURE

When the operation is in the right side, the Azygous vein bow is used as the marker, and in the left side, the aortic arch is used as the marker to identify the vagus nerve trunk.Then the surgeons dissect the vagus nerve trunk. This is used as a clue to find the vagus nerve pulmonary branch leading to the hilum. The position of the detachment is after the anterior and posterior pulmonary branches of the vagus nerve separating from the trunk and before the formation of the lung plexus.

Group D

Eligibility Criteria

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

You may qualify if:

• Patients with preoperative imaging of bronchial lung cancer below the secondary bronchus ,the maximum diameter of the tumor ≤ 5cm (T ≤ 2) and staging check not suggesting distant and mediastinal lymph node metastasis (N ≤ 1, M = 0) schedule to receive elective unilateral thoracoscopic lobectomy from 2019 to 2021 will be included in the trial.
• ASAⅠ-Ⅲ

You may not qualify if:

• Chronic cough (\>8 weeks), its causes including chronic bronchitis, asthma, gastroesophageal reflux disease, history of postnasal drip syndrome, and the use of ACEI drugs and so on;
• other history of lung surgery;
• patients with severe arrhythmia;
• there are contraindications for anesthesia and surgery;
• pregnancy and lactation.

Sponsors & Collaborators

• Han Yuan: lead

Study Sites (1)

Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 225000, China

Location

Related Publications (1)

• 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 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor-in-charge of Anesthetist

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: January 30, 2020
• Study Start: February 1, 2020
• Primary Completion: November 1, 2020
• Study Completion: February 1, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

CN (1)