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NCT Number: 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

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.

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Key information

Conditions

Video-Assisted Thoracoscopic Surgery Inflammation Inflammatory Reaction Life Scores Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shengjing Hospital

Shenyang, Liaoning, 110004, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.).

Treatment and study plan

uni-portal VATS group

Other

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

three port VATS group

Other

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

Primary outcomes

  1. intraoperative hemorrhage volume

    Time frame: at the end of the surgery

    record intraoperative hemorrhage volume at the end of the surgery

  2. chest drainage time

    Time frame: before remove drainage tube

    record chest drainage time until remove drainage tube

  3. duration of the healing of incision

    Time frame: before suture removal

    record the duration of the healing of incision

  4. out-of-bed activity time (Day) and length of hospital stay (Day)

    Time frame: Before discharge from hospital

    record the days of patients' out-of-bed activity time and length of hospital stay after surgery

  5. postoperative pain

    Time frame: 24 hours after surgery

    record postoperative pain 24 hours after surgery by using visual analog scale (VAS) score, where 0 indicates painlessness, and 10 indicates severe pain

  6. postoperative adverse effects

    Time frame: 24 hours after surgery

    record postoperative adverse effects 24 hours after surgery

  7. preoperative inflammation

    Time frame: two days before operation

    record c-reactive protein after surgery

  8. inflammation at end of operation

    Time frame: end of operation

    record c-reactive protein after surgery

  9. postoperative inflammation

    Time frame: 30mins after operation

    record c-reactive protein after surgery

  10. postoperative inflammation

    Time frame: Day 1 after operation

    record c-reactive protein after surgery

  11. postoperative inflammation

    Time frame: Day 3 after operation

    record c-reactive protein after surgery

  12. preoperative inflammation

    Time frame: two days before operation

    record serum amyloid A protein (SAA) after surgery

  13. inflammation at end of operation

    Time frame: end of operation

    record serum amyloid A protein (SAA) after surgery

  14. postoperative inflammation

    Time frame: 30mins after operation

    record serum amyloid A protein (SAA) after surgery

  15. postoperative inflammation

    Time frame: Day 1 after operation

    record serum amyloid A protein (SAA) after surgery

  16. postoperative inflammation

    Time frame: Day 3 after operation

    record serum amyloid A protein (SAA) after surgery

  17. preoperative inflammation

    Time frame: two days before operation

    record IL-6 after surgery

  18. inflammation at end of operation

    Time frame: end of operation

    record IL-6 after surgery

  19. postoperative inflammation

    Time frame: 30mins after operation

    record IL-6 after surgery

  20. postoperative inflammation

    Time frame: Day 1 after operation

    record IL-6 after surgery

  21. postoperative inflammation

    Time frame: Day 7 after operation

    record IL-6 after surgery

Sponsors and collaborators

Lead sponsor

Shengjing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 6, 2021
Registry last updated
Aug 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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