- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04651686
Effect of Bronchial Artery Protection on Cough After Thoracoscopic Lobectomy
November 25, 2020 updated by: The First Affiliated Hospital of Soochow University
Effect of Preoperative Three-dimensional Reconstruction and Intraoperative Protection of Bronchial Artery on Cough After Thoracoscopic Pneumonectomy
The postoperative complications of thoracoscopic radical surgery for lung cancer mainly include postoperative bleeding, pulmonary infection, chylothorax, nerve injury, pulmonary embolism, arrhythmia, postoperative cough, bronchopleural fistula and so on.
Among them, postoperative cough is one of the most common complications after lung surgery, and the incidence of postoperative cough is 25% - 50%.
Cough after pneumonectomy can last for a long time, which affects the rapid recovery of patients after surgery, and brings serious adverse effects to the physiological, psychological and social functions of patients.
Study Overview
Status
Completed
Conditions
Detailed Description
After pneumonectomy cough on patients' daily life will bring different degrees of adverse effects, so through certain methods to intervene, in order to reduce the incidence of postoperative cough, accelerate the rapid recovery of patients after surgery, improve the quality of life of patients, which should also be worthy of attention of surgeons.
In recent years, the research on intervention measures and treatment methods to reduce cough after thoracoscopic lobectomy is mainly focused on drug treatment, traditional Chinese medicine treatment, surgical operation and anesthesia intervention.
However, the research on reducing postoperative cough by improving surgical operation is rare.
The purpose of this prospective study was to investigate whether preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery can reduce the severity of cough after thoracoscopic lobectomy, so as to further explore the effective intervention measures of postoperative cough and enrich the concept of accelerated rehabilitation surgery.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
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Suzhou, Jiangsu, China, 215006
- Li Chang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age ≥ 18 years, no matter male or female;No cough symptoms within two weeks before operation; Lung adenocarcinoma confirmed by pathology;Operation method: thoracoscopic lobectomy + systematic lymph node dissection;Preoperative abdominal B-ultrasound, skull CT / MRI, bone scan or PET / CT to exclude distant metastasis; ECG, lung function, cardiac ultrasound evaluation can tolerate the operation
Exclusion Criteria:
- There were cough caused by respiratory diseases, pharyngitis and rhinitis before operation; Pneumonia was indicated by chest X-ray or chest CT in recent month;Thoracoscopic surgery was converted to thoracotomy;Pulmonary arteriovenous angiography could not be performed in patients with allergy to contrast medium; Patients and their families refused to be enrolled and followed up.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Bronchial artery protection
All patients underwent chest enhanced CT examination with 64 slice spiral CT before operation.
The bronchial artery was reconstructed by Mimics software.
The bronchial artery was protected according to the preoperative three-dimensional reconstruction image during the lymph node dissection
|
All patients underwent chest enhanced CT examination with 64 slice spiral CT before operation.
The bronchial artery was reconstructed by Mimics software.
The bronchial artery was protected according to the preoperative three-dimensional reconstruction image during the lymph node dissection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of postoperative cough
Time Frame: It lasted for 14 days from the first day to two weeks after operation
|
Cough visual analogue scale (VAS) was used to evaluate the diagnosis of cough.
Vas is a linear scoring method, using 0-100 mm scale, 0 means no cough, 100 means the most serious cough.
Patients are required to mark the severity of cough on the scale line according to their own perception of cough, and measure the distance from the starting point to the marking point as a score.
The higher the score is, the more serious the cough is.
When the scale reaches 60mm, the patient can be diagnosed as postoperative cough.
|
It lasted for 14 days from the first day to two weeks after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jun Zhao, the First Affiliated Hospital of Soochow University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Morita Y, Takase K, Ichikawa H, Yamada T, Sato A, Higano S, Takahashi S. Bronchial artery anatomy: preoperative 3D simulation with multidetector CT. Radiology. 2010 Jun;255(3):934-43. doi: 10.1148/radiol.10081220.
- Zhang M, Liu D, Wu W, Zhang H, Mao N. Preoperative 3D-CT bronchography and angiography facilitates single-direction uniportal thoracoscopic anatomic lobectomy. Ann Transl Med. 2019 Oct;7(20):526. doi: 10.21037/atm.2019.09.135.
- Anuradha C, Shyamkumar NK, Vinu M, Babu NR, Christopher DJ. Outcomes of bronchial artery embolization for life-threatening hemoptysis due to tuberculosis and post-tuberculosis sequelae. Diagn Interv Radiol. 2012 Jan-Feb;18(1):96-101. doi: 10.4261/1305-3825.DIR.3876-11.2. Epub 2011 Jun 15.
- Zhu YF, Wu SB, Zhou MQ, Xie MR, Xiong R, Xu SB, Xu GW. Increased expression of TRPV1 in patients with acute or chronic cough after lung cancer surgery. Thorac Cancer. 2019 Apr;10(4):988-991. doi: 10.1111/1759-7714.13042. Epub 2019 Mar 18.
- Funami Y, Okuyama K, Shimada Y, Isono K. Anatomic study of the bronchial arteries with special reference to their preservation during the radical dissection of the upper mediastinum lymph nodes. Surgery. 1996 Jan;119(1):67-75. doi: 10.1016/s0039-6060(96)80216-9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2020
Primary Completion (Actual)
September 30, 2020
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
November 22, 2020
First Submitted That Met QC Criteria
November 25, 2020
First Posted (Actual)
December 3, 2020
Study Record Updates
Last Update Posted (Actual)
December 3, 2020
Last Update Submitted That Met QC Criteria
November 25, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20201114
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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