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Hemodynamic and Inflammatory Responses in Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT02647775
Recruitment Status : Completed
First Posted : January 6, 2016
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Brief Summary:
Video-assisted thoracoscopic surgery (VATS) for thoracic surgery is practical, has been shown to reduce postoperative discomfort, and has improved cosmetic results when compare to open thoracotomy. The specific aims of this project are: to clarify the physiologic and immunologic effects of different approaches for minimally invasive thoracic surgery: (1) multiple-port VATS; (2) single-port VATS

Condition or disease Intervention/treatment Phase
Video-Assisted Thoracic Surgery Procedure: multi-port VATS Procedure: single-port VATS Not Applicable

Detailed Description:

Video-assisted thoracoscopic surgery (VATS) was first reported in the early 1990s. Since then, the safety and efficacy of thoracoscopy for diagnosing and treating pleural, pulmonary, and mediastinal disease has been demonstrated with similar oncological results, which were confirmed by multiple clinical studies. Although VATS for thoracic surgery is practical, has been shown to reduce postoperative discomfort, and has improved cosmetic results when compare to open thoracotomy, unfortunately chronic thoracic wound discomfort and postoperative neuralgia were found in a significant portion of patients .

Recently, a minimally invasive approach that is different from the conventional multiport thoracoscopic technique is gradually becoming of great interest in the diagnosis and treatment of thoracic surgical disease. Single-port VATS is one of the most promising emerging surgical techniques which allows the surgeon to perform a majority of thoracic surgeries and with similar perioperative outcomes that are comparable with the conventional multiport technique. However, a very limited number of clinical studies have demonstrated the advantages of single port VATS in postoperative pain reduction, when comparing to the traditional multiport thoracoscopic approach.

To clarify the physiologic and immunologic effects of different approaches for minimally invasive thoracic surgery, investigators aim to compare the perioperative physiological changes, immunological responses, and postoperative pain between standard (multi-port) transthoracic thoracoscopic and single-port transthoracic thoracoscopic surgery for thoracic disease.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemodynamic and Inflammatory Responses in Thoracic Surgery: Hemodynamic and Inflammatory Responses Following Video-assisted Thoracoscopic Surgery
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : December 2018

Arm Intervention/treatment
multi-port VATS
Multi-port VATS is an operative method
Procedure: multi-port VATS
Patients with thoracic surgical diseases who underwent VATS will be recruited into this study to investigate the postoperative pain , physiologic and immunologic impacts of two different approaches for minimally invasive thoracic surgery.

single-port VATS
Single-port VATS is an operative method
Procedure: single-port VATS
Patients with thoracic surgical diseases who underwent VATS will be recruited into this study to investigate the postoperative pain , physiologic and immunologic impacts of two different approaches for minimally invasive thoracic surgery.




Primary Outcome Measures :
  1. Pain score [ Time Frame: beginning at 3 hours after surgery until 5 days ]
    Numerical Rating Scale (NRS) or Wong-Baker Face Pain Rating Scale


Secondary Outcome Measures :
  1. Complication [ Time Frame: beginning at 3 hours after surgery until 30 days ]
    Yes/No

  2. Mean arterial pressure [ Time Frame: beginning 20 min before the start of surgery until 20 min after the surgery. ]
    MAP; mmHg

  3. Heart rate [ Time Frame: beginning 20 min before the start of surgery until 20 min after the surgery. ]
    HR; beats per min [bpm]

  4. Cardiac index [ Time Frame: beginning 20 min before the start of surgery until 20 min after the surgery. ]
    CI; L/[min·m2]

  5. Systemic vascular resistance index [ Time Frame: beginning 20 min before the start of surgery until 20 min after the surgery. ]
    SVRI; [dyn·s]/[cm-5·m2]

  6. Global end-diastolic volume index [ Time Frame: beginning 20 min before the start of surgery until 20 min after the surgery. ]
    GEDVI; mL/m2

  7. Leukocyte subset analysis [ Time Frame: preoperation till 5 days after surgery ]
    10^3/ul

  8. Intracellular oxidative activity of neutrophils [ Time Frame: preoperation till 5 days after surgery ]
    ratio compared with preoperation

  9. Inducible nitric oxide synthase expression in monocytes [ Time Frame: preoperation till 5 days after surgery ]
    Arbitrary intensity

  10. Interleukin-6 [ Time Frame: preoperation till 5 days after surgery ]
    pg/ml

  11. C-reactive protein [ Time Frame: preoperation till 5 days after surgery ]
    ng/ml



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with thoracic surgical diseases(lung cancer. mediastinal tumor. solitary pulmonary lesion. pneumothorax) who will be underwent video-assisted thoracic surgery

Exclusion Criteria:

  • Unresectable mediastinal tumor
  • Previous history of ipsilateral pulmonary resection
  • Patients with complex cardiopulmonary dysfunction
  • Unresectable pulmonary hilar tumor

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02647775


Locations
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Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Principal Investigator: Yun-Hen Liu Chang Gung Memorial Hospital
Principal Investigator: Hung-Pin Liu Chang Gung Memorial Hospital
Principal Investigator: Yi-Cheng Wu Chang Gung Memorial Hospital
Principal Investigator: Ming-Ju Hsieh Chang Gung Memorial Hospital
Principal Investigator: Wei-Hsun Chen Chang Gung Memorial Hospital
Principal Investigator: Yen Chu Chang Gung Memorial Hospital
Principal Investigator: Chien-Ying Liu Chang Gung Memorial Hospital
Publications:

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02647775    
Other Study ID Numbers: CGMH-IRB-104-7159A3
First Posted: January 6, 2016    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected IPD, all IPD that underlie results in a publication
Time Frame: Starting 6 months after publication
Keywords provided by Chang Gung Memorial Hospital:
Thoracoscopic surgery
Additional relevant MeSH terms:
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Aneurysm, Dissecting
Aneurysm
Vascular Diseases
Cardiovascular Diseases