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

NCT05070026 | Completed

• 1 other identifier: uni-portal and three port VATS
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Video-assisted Thoracoscopic Surgery; Inflammatory Reaction; Life Scores

Outcome Measures

Primary Outcomes (21)

• 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

Study Arms (2)

uni-portal VATS group

EXPERIMENTAL

Other: uni-portal VATS group

three port VATS group

EXPERIMENTAL

Other: three port VATS group

Interventions

uni-portal VATS group OTHER

patients received pulmonary lobectomy under general anesthesia by using uni-portal VATS method

uni-portal VATS group

three port VATS group OTHER

patients received pulmonary lobectomy under under general anesthesia by using three port VATS method

three port VATS group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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.).

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: October 6, 2021
• Study Start: October 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: August 16, 2022

Record last verified: 2022-08

Locations

CN (1)