Comparison of Inflammatory Cytokine Levels Between Single-port and Three-port Thoracoscopic Lobectomy in the Treatment of Non-small Cell Lung Cancersurgery on Perioperative Clinical Indexes、Inflammatory Reaction and Quality of Life Scores of Patients With Non-small Cell Lung Cancer

Study Overview
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Brief Summary
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Many recent studies have shown that surgical trauma will result in an immunosuppressive state. Combined with the effect of surgical stress, it will often lead to metabolic changes, systemic inflammatory response, and other problems. The body resists and removes the harmful factors through the inflammatory reaction. However, an excessive reaction will damage the normal tissues and cells of the body. The smooth recovery of the body needs to balance the degree of inflammatory reaction. Surgical patients will trigger different degrees of an inflammatory response due to different degrees of physical trauma, which runs through the process of postoperative recovery from the beginning of surgery and often prolongs the time of postoperative recovery. Reducing the intraoperative and postoperative inflammatory response of patients has always been the goal of surgeons, and a method is the reduction of surgical trauma. The successful experience of the first single-port thoracoscopic wedge resection of the lung in 2004 provided us with a new surgical idea. Subsequently, a large number of domestic and international studies and case reports show that single-port thoracoscopic surgery is safe and feasible in lobectomy and segmental resection. With the rapid development of single-port thoracoscopic surgery in recent years, the scope of application and clinical efficacy of the surgery are gradually becoming equivalent to the traditional three-port thoracoscopic surgery, which can ensure the safety of the operation and complete tumor resection, and has its own characteristics and advantages compared with the traditional three-port thoracoscopic surgery. The reduction of incisions can significantly improve the postoperative pain and recovery of patients and wound healing. In addition, single-port thoracoscopic surgery also has a subtle improvement in patients' intraoperative and postoperative inflammatory response compared with traditional three-port thoracoscopic surgery. In this study, we compared and analyzed the intraoperative and postoperative inflammatory factor levels of single-port thoracoscopic surgery and three-port thoracoscopic surgery in patients with non-small cell lung cancer (NSCLC). Through the comparison of the measured values, we further discussed the advantages of single-port thoracoscopic surgery in reducing inflammatory response and its application and promotion value in the treatment of patients with NSCLC compared with traditional three-port thoracoscopic surgery.

Official Title
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Comparison of Inflammatory Cytokine Levels Between Single-port and Three-port Thoracoscopic Lobectomy in the Treatment of Non-small Cell Lung Cancer

Conditions
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Video-assisted Thoracoscopic Surgery, Inflammatory Reaction, Life Scores

Intervention / Treatment
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* Other: uni-portal VATS group
* Other: three port VATS group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) NSCLC was diagnosed by imaging examination (chest enhanced computed tomography or positron emission tomography-computed tomography) and biopsy pathology; (2) TNM stage was stage I and II; (3) the patient had indications of radical operation; (4) the patient had good cardiopulmonary, liver, and kidney function and no obvious surgical contraindication before operation; (5) the preoperative inflammatory indexes of all patients were within the normal range Exclusion Criteria: (1) the thoracoscopic operation was converted to thoractomy; (2) the operation time was more than 3 hours; (3) blood vessel rupture occurred during the operation, and the bleeding amount was more than 200 mL; (4) the patient had complications (the patient had fever exceeding 38.5 ℃, chest computed tomography confirmed intrapulmonary infection, incision infection, postoperative bleeding, requiring secondary thoracotomy, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: uni-portal VATS group<br> | Other: uni-portal VATS group<br>* patients received pulmonary lobectomy under general anesthesia by using uni-portal VATS method<br>|
| Experimental: three port VATS group<br> | Other: three port VATS group<br>* patients received pulmonary lobectomy under under general anesthesia by using three port VATS method<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative hemorrhage volume | record intraoperative hemorrhage volume at the end of the surgery | at the end of the surgery | 
| chest drainage time | record chest drainage time until remove drainage tube | before remove drainage tube | 
| duration of the healing of incision | record the duration of the healing of incision | before suture removal | 
| out-of-bed activity time (Day) and length of hospital stay (Day) | record the days of patients' out-of-bed activity time and length of hospital stay after surgery | Before discharge from hospital | 
| postoperative pain | record postoperative pain 24 hours after surgery by using visual analog scale (VAS) score, where 0 indicates painlessness, and 10 indicates severe pain | 24 hours after surgery | 
| postoperative adverse effects | record postoperative adverse effects 24 hours after surgery | 24 hours after surgery | 
| preoperative inflammation | record c-reactive protein after surgery | two days before operation | 
| inflammation at end of operation | record c-reactive protein after surgery | end of operation | 
| postoperative inflammation | record c-reactive protein after surgery | 30mins after operation | 
| postoperative inflammation | record c-reactive protein after surgery | Day 1 after operation | 
| postoperative inflammation | record c-reactive protein after surgery | Day 3 after operation | 
| preoperative inflammation | record serum amyloid A protein (SAA) after surgery | two days before operation | 
| inflammation at end of operation | record serum amyloid A protein (SAA) after surgery | end of operation | 
| postoperative inflammation | record serum amyloid A protein (SAA) after surgery | 30mins after operation | 
| postoperative inflammation | record serum amyloid A protein (SAA) after surgery | Day 1 after operation | 
| postoperative inflammation | record serum amyloid A protein (SAA) after surgery | Day 3 after operation | 
| preoperative inflammation | record IL-6 after surgery | two days before operation | 
| inflammation at end of operation | record IL-6 after surgery | end of operation | 
| postoperative inflammation | record IL-6 after surgery | 30mins after operation | 
| postoperative inflammation | record IL-6 after surgery | Day 1 after operation | 
| postoperative inflammation | record IL-6 after surgery | Day 7 after operation |