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NCT Number: NCT02647775

Hemodynamic and Inflammatory Responses in Thoracic Surgery

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

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Key information

Conditions

Video-Assisted Thoracic Surgery

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Taoyuan, 333, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

multi-port VATS

Procedure

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

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

Hemodynamic and Inflammatory Responses in Thoracic Surgery: Hemodynamic and Inflammatory Responses Following Video-assisted Thoracoscopic Surgery

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 6, 2016
Registry last updated
Jan 22, 2020

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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