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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04651686
Other study ID # 20201114
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2020
Est. completion date November 1, 2020

Study information

Verified date November 2020
Source The First Affiliated Hospital of Soochow University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 1, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery
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

Locations

Country Name City State
China Li Chang Suzhou Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of postoperative cough 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
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