Clinical trial NCT05070026: 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
Official title: Comparison of Inflammatory Cytokine Levels Between Single-port and Three-port Thoracoscopic Lobectomy in the Treatment of Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Video-assisted Thoracoscopic Surgery
Inflammatory Reaction
Life Scores
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.).

Primary outcomes:
measure: intraoperative hemorrhage volume
timeFrame: at the end of the surgery
measure: chest drainage time
timeFrame: before remove drainage tube
measure: duration of the healing of incision
timeFrame: before suture removal
measure: out-of-bed activity time (Day) and length of hospital stay (Day)
timeFrame: Before discharge from hospital
measure: postoperative pain
timeFrame: 24 hours after surgery
measure: postoperative adverse effects
timeFrame: 24 hours after surgery
measure: preoperative inflammation
timeFrame: two days before operation
measure: inflammation at end of operation
timeFrame: end of operation
measure: postoperative inflammation
timeFrame: 30mins after operation
measure: postoperative inflammation
timeFrame: Day 1 after operation
measure: postoperative inflammation
timeFrame: Day 3 after operation
measure: preoperative inflammation
timeFrame: two days before operation
measure: inflammation at end of operation
timeFrame: end of operation
measure: postoperative inflammation
timeFrame: 30mins after operation
measure: postoperative inflammation
timeFrame: Day 1 after operation
measure: postoperative inflammation
timeFrame: Day 3 after operation
measure: preoperative inflammation
timeFrame: two days before operation
measure: inflammation at end of operation
timeFrame: end of operation
measure: postoperative inflammation
timeFrame: 30mins after operation
measure: postoperative inflammation
timeFrame: Day 1 after operation
measure: postoperative inflammation
timeFrame: Day 7 after operation
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Shengjing Hospital
state: Liaoning
Study officials:
References: