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

NCT ID: NCT04247997

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2023-02-01

Brief Summary

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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.

Detailed Description

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After screening for the Inclusion criteria and the exclusion criteria, 116 patients undergoing unilateral thoracoscopic lobectomy are randomly assigned to two groups, disconnecting pulmonary vague nerve branches and preserving pulmonary vague nerve branches. The incidence of chronic cough after surgery is compared between groups.

Conditions

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Postoperative Chronic Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Group D

disconnect pulmonary vague nerve branches

Group Type EXPERIMENTAL

disconnect pulmonary vague nerve branches

Intervention Type 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 P

preserve the pulmonary vague nerve branches

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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disconnect pulmonary vague nerve branches

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Han Yuan

OTHER

Sponsor Role lead

Responsible Party

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Han Yuan

Doctor-in-charge of Anesthetist

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 38116674 (View on PubMed)

Other Identifiers

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XYFY2019-KL179-01

Identifier Type: -

Identifier Source: org_study_id

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