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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 Cancersurgery on Perioperative Clinical Indexes、Inflammatory Reaction and Quality of Life Scores of Patients With Non-small Cell Lung Cancer

Primary Purpose

Video-assisted Thoracoscopic Surgery, Inflammatory Reaction, Life Scores

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
uni-portal VATS group
three port VATS group
Sponsored by
Shengjing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Video-assisted Thoracoscopic Surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.).

Sites / Locations

  • Shengjing Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

uni-portal VATS group

three port VATS group

Arm Description

Outcomes

Primary Outcome Measures

intraoperative hemorrhage volume
record intraoperative hemorrhage volume at the end of the surgery
chest drainage time
record chest drainage time until remove drainage tube
duration of the healing of incision
record the duration of the healing of incision
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
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
postoperative adverse effects
record postoperative adverse effects 24 hours after surgery
preoperative inflammation
record c-reactive protein after surgery
inflammation at end of operation
record c-reactive protein after surgery
postoperative inflammation
record c-reactive protein after surgery
postoperative inflammation
record c-reactive protein after surgery
postoperative inflammation
record c-reactive protein after surgery
preoperative inflammation
record serum amyloid A protein (SAA) after surgery
inflammation at end of operation
record serum amyloid A protein (SAA) after surgery
postoperative inflammation
record serum amyloid A protein (SAA) after surgery
postoperative inflammation
record serum amyloid A protein (SAA) after surgery
postoperative inflammation
record serum amyloid A protein (SAA) after surgery
preoperative inflammation
record IL-6 after surgery
inflammation at end of operation
record IL-6 after surgery
postoperative inflammation
record IL-6 after surgery
postoperative inflammation
record IL-6 after surgery
postoperative inflammation
record IL-6 after surgery

Secondary Outcome Measures

Full Information

First Posted
September 12, 2021
Last Updated
August 13, 2022
Sponsor
Shengjing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05070026
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shengjing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Video-assisted Thoracoscopic Surgery, Inflammatory Reaction, Life Scores

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
uni-portal VATS group
Arm Type
Experimental
Arm Title
three port VATS group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
uni-portal VATS group
Intervention Description
patients received pulmonary lobectomy under general anesthesia by using uni-portal VATS method
Intervention Type
Other
Intervention Name(s)
three port VATS group
Intervention Description
patients received pulmonary lobectomy under under general anesthesia by using three port VATS method
Primary Outcome Measure Information:
Title
intraoperative hemorrhage volume
Description
record intraoperative hemorrhage volume at the end of the surgery
Time Frame
at the end of the surgery
Title
chest drainage time
Description
record chest drainage time until remove drainage tube
Time Frame
before remove drainage tube
Title
duration of the healing of incision
Description
record the duration of the healing of incision
Time Frame
before suture removal
Title
out-of-bed activity time (Day) and length of hospital stay (Day)
Description
record the days of patients' out-of-bed activity time and length of hospital stay after surgery
Time Frame
Before discharge from hospital
Title
postoperative pain
Description
record postoperative pain 24 hours after surgery by using visual analog scale (VAS) score, where 0 indicates painlessness, and 10 indicates severe pain
Time Frame
24 hours after surgery
Title
postoperative adverse effects
Description
record postoperative adverse effects 24 hours after surgery
Time Frame
24 hours after surgery
Title
preoperative inflammation
Description
record c-reactive protein after surgery
Time Frame
two days before operation
Title
inflammation at end of operation
Description
record c-reactive protein after surgery
Time Frame
end of operation
Title
postoperative inflammation
Description
record c-reactive protein after surgery
Time Frame
30mins after operation
Title
postoperative inflammation
Description
record c-reactive protein after surgery
Time Frame
Day 1 after operation
Title
postoperative inflammation
Description
record c-reactive protein after surgery
Time Frame
Day 3 after operation
Title
preoperative inflammation
Description
record serum amyloid A protein (SAA) after surgery
Time Frame
two days before operation
Title
inflammation at end of operation
Description
record serum amyloid A protein (SAA) after surgery
Time Frame
end of operation
Title
postoperative inflammation
Description
record serum amyloid A protein (SAA) after surgery
Time Frame
30mins after operation
Title
postoperative inflammation
Description
record serum amyloid A protein (SAA) after surgery
Time Frame
Day 1 after operation
Title
postoperative inflammation
Description
record serum amyloid A protein (SAA) after surgery
Time Frame
Day 3 after operation
Title
preoperative inflammation
Description
record IL-6 after surgery
Time Frame
two days before operation
Title
inflammation at end of operation
Description
record IL-6 after surgery
Time Frame
end of operation
Title
postoperative inflammation
Description
record IL-6 after surgery
Time Frame
30mins after operation
Title
postoperative inflammation
Description
record IL-6 after surgery
Time Frame
Day 1 after operation
Title
postoperative inflammation
Description
record IL-6 after surgery
Time Frame
Day 7 after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.).
Facility Information:
Facility Name
Shengjing Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110004
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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