Postoperative Chronic CoughNCT04247997
Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy
A study testing disconnect pulmonary vague nerve branches in people with Postoperative Chronic Cough, run by Han Yuan at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Chronic Cough
- What is being tested?
- disconnect pulmonary vague nerve branches
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 1 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 225000
About this study
Official title: Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy: a Single-center, Randomized ,Single-blind, Controlled Trial
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.
Read the 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.
- Conditions
- Postoperative Chronic Cough
- Being tested
- disconnect pulmonary vague nerve branches
- Keywords
- postoperative chronic cough, pulmonary vagus nerve branch, autonomic nervous system, pulmonary nerves, thoracoscopic lobectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
disconnect pulmonary vague nerve branchesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group D | Experimental | disconnect pulmonary vague nerve branches Receives: Procedure: disconnect pulmonary vague nerve branches |
| Group P | No intervention | preserve the pulmonary vague nerve branches |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
Secondary outcomes (12)
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.
Measured: 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.
Measured: 1 month and 3 months after surgery
Length of operation
Measured: during the operation
volume of bleeding
Measured: during the operation
volume of postoperative drainage
Measured: within 30 days after surgery
the frequence of perioperative arrhythmia
Measured: during the operation
the incidence of Postoperative complication
pulmonary complications, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, wound infection, cerebrovascular accident
Measured: 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.
Measured: postoperative 1 day,2 days,3 days,4 days,5 days,6 days
the time of extubation
Measured: within 30 days after surgery
the incidence of gastrointestinal symptoms
gastrointestinal symptoms include anorexia, belching, reflux, diarrhea, nausea
Measured: within 3 months after surgery
the incidence of postoperative hospitalization
Measured: 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
Measured: 30 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start1 Feb 2020
- Primary completion1 Nov 2020
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Han Yuan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Han Yuan, Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247997
- Sponsor's protocol ID
- XYFY2019-KL179-01
- Status last verified
- Jun 2023
- First submitted
- 27 Nov 2019
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38116674
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Disconnecting Pulmonary Vagus Nerve Branch on Chronic Cough After Unilateral Thoracoscopic Lobectomy: a Single-center, Randomized ,Single-blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT04247997
- Acronym / sponsor ID
- XYFY2019-KL179-01
- Conditions
- Postoperative Chronic Cough
- Keywords
- postoperative chronic cough, pulmonary vagus nerve branch, autonomic nervous system, pulmonary nerves, thoracoscopic lobectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Han YuanUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D | Experimental | Procedure: disconnect pulmonary vague nerve branchesdisconnect pulmonary vague nerve branches |
| Group P | No intervention | –preserve the pulmonary vague nerve branches |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| disconnect pulmonary vague nerve branchesWhen 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. | Procedure or surgery | Group D |
Primary outcome
The incidence of chronic cough after surgery
Time frame: 3 months 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.
12 secondary outcomes
The incidence of chronic cough after surgery
Time frame: 1 month after surgery
The score of the LCQ-MC scale after surgery
Time frame: 1 month and 3 months after surgery
Length of operation
Time frame: during the operation
volume of bleeding
Time frame: during the operation
volume of postoperative drainage
Time frame: within 30 days after surgery
the frequence of perioperative arrhythmia
Time frame: during the operation
the incidence of Postoperative complication
Time frame: within 30 days after surgery
the score of Cough symptom
Time frame: postoperative 1 day,2 days,3 days,4 days,5 days,6 days
the time of extubation
Time frame: within 30 days after surgery
the incidence of gastrointestinal symptoms
Time frame: within 3 months after surgery
the incidence of postoperative hospitalization
Time frame: within 30 days after surgery
pulmonary function 30 months after surgery
Time frame: 30 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Derived from this study: PubMed 38116674Zhang 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.
Related trials for Postoperative Chronic Cough
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Postoperative Cough, Cough Hypersensitivity Syndrome
Not yet recruiting
A Prospective, Randomized, Double-blind Study on the Effects of Different Anesthesia Strategies on Postoperative Cough in Patients Undergoing Video-assisted Thoracoscopic Surgery.
Chronic Cough, Video-assisted Thoracoscopic Surgery (VATS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing disconnect pulmonary vague nerve branches in people with Postoperative Chronic Cough, run by Han Yuan at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of chronic cough after surgery (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04247997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.