Through prospective, randomized and controlled clinical study, patients with early lung cancer who do not need lymph node dissection according to routine diagnosis and treatment were selected. The feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were compared with traditional minimally invasive surgery, and the feasibility and safety of preserving vagal pulmonary branch intact during minimally invasive surgery were clarified. The effect of preserving pulmonary branches of vagus nerve in minimally invasive surgery of early lung cancer on preventing or reducing pulmonary complications after operation was evaluated by main observation indexes (incidence of pulmonary complications) and secondary evaluation indexes. It will provide a safer, simpler and more effective new technology for patients with early lung cancer undergoing minimally invasive surgery, and provide a basis for the popularization of this new technology.
According to the suggestion of statistical experts and the minimum sample size, 120 IA1-2 patients who are going to undergo thoracoscopic lung surgery were selected according to the criteria of admission and exclusion. The risk and benefit were informed and the informed consent of the subjects was signed. The patients were numbered and randomly divided into two groups: group A with vagus nerve preservation during minimally invasive surgery and group B with traditional minimally invasive surgery for early lung cancer. The incidence of pulmonary complications within 5 weeks after operation (see the evaluation criteria for details), operation time, intraoperative bleeding volume, postoperative drainage volume, postoperative mortality, incidence of cardiovascular complications, rate of re-tracheal intubation, rate of re-admission to ICU, duration of stay in ICU, hospitalization costs were observed. Statistical analysis and evaluation of the safety of preserving pulmonary branches of vagus nerve in minimally invasive surgery and the effectiveness of preventing or reducing pulmonary complications after minimally invasive surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve
In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve.
Yongxin Zhou
Shanghai, Shanghai Municipality, China
RECRUITINGcough after pulmonary resection
(1) dry cough lasting no less than 2 weeks after pneumonectomy; (2) no obvious abnormalities in chest X-ray; (3) excluding drug factors such as postnasal drip syndrome, bronchial asthma and ACEI
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
pulmonary infection
Postoperative pneumonia should be considered if there are three or more of the following indicators: 1. Fever occurred 72 hours after operation, and the body temperature increased again within T \> 38 C or 72 hours. 2. Leukocyte count increased (\>12-15\*109/L) or increased again after the leucocyte count returned to normal value, exceeding 10\*109/L; 3. Chest imaging showed consolidation of lung tissue or increasing patchy shadow; 4. cough up purulent sputum or sputum culture positive; If it contains 4, only one of the other items can be considered as a respiratory consultation to determine pulmonary infection, and need to replace antibiotics or prolong the use of antibiotics.
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Atelectasis
(1) Imaging findings suggest atelectasis or consolidation of the lungs; (2) signs of dyspnea; (3) decreased oxygen saturation to below 90%.
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
hydrothorax
Re-catheterization was needed; dyspnea symptoms; and drainage time was longer than 15 days.
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Postoperative respiratory failure or ARDS or requiring tracheal intubation
Tracheal intubation; Ventilator; ICU
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Operation time;
Operation time;
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Intraoperative bleeding volume;
Intraoperative bleeding volume;
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Postoperative drainage volume;
Postoperative drainage volume;
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Postoperative mortality
Postoperative mortality
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Postoperative cardiovascular complications
Postoperative cardiovascular complications
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Re-admission ICU rate;
Re-admission ICU rate;
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Time of stay in ICU;
Time of stay in ICU;
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
Hospitalization days
Hospitalization days
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.
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Hospitalization expenses
Hospitalization expenses
Time frame: From the date of randomized grouping to 5 weeks after operation, the evaluation time was as long as 5 weeks.