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

Study Overview
=================
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy: a Single-center, Randomized ,Single-blind, Controlled Trial

Conditions
-----------------
Postoperative Chronic Cough

Intervention / Treatment
-----------------
* Procedure: disconnect pulmonary vague nerve branches


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group D<br>disconnect pulmonary vague nerve branches | Procedure: disconnect pulmonary vague nerve branches<br>* 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.<br>|
| No Intervention: Group P<br>preserve the pulmonary vague nerve branches | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month after surgery | 
| The score of the LCQ-MC scale after surgery | The LCQ-MC was designed for the assessment of a chronic cough, consists of 19 items and three domains. | 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 | 
| the frequence of perioperative arrhythmia |  | during the operation | 
| the incidence of Postoperative complication | pulmonary complications, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, wound infection, cerebrovascular accident | within 30 days after surgery | 
| the score of Cough symptom | The score was used to record daily symptom score for cough severity.The scale is scored by 4 levels at day and night respectively.The higher score means worse symptom. | postoperative 1 day,2 days,3 days,4 days,5 days,6 days | 
| the time of extubation |  | within 30 days after surgery | 
| the incidence of gastrointestinal symptoms | gastrointestinal symptoms include anorexia, belching, reflux, diarrhea, nausea | within 3 months after surgery | 
| the incidence of postoperative hospitalization |  | within 30 days after surgery | 
| pulmonary function 30 months after surgery | maximal voluntary ventilation, diffusing capacity of the lungs for carbon monoxideand forced expiratory volume | 30 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autonomic nervous system, postoperative chronic cough, pulmonary vagus nerve branch, pulmonary nerves, thoracoscopic lobectomy