Hemodynamic and Inflammatory Responses in Thoracic Surgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Video-Assisted Thoracic Surgery

Intervention / Treatment
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* Procedure: multi-port VATS
* Procedure: single-port VATS


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: multi-port VATS<br>Multi-port VATS is an operative method | Procedure: multi-port VATS<br>* 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.<br>|
| Other: single-port VATS<br>Single-port VATS is an operative method | Procedure: single-port VATS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Numerical Rating Scale (NRS) or Wong-Baker Face Pain Rating Scale | beginning at 3 hours after surgery until 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication | Yes/No | beginning at 3 hours after surgery until 30 days | 
| Mean arterial pressure | MAP; mmHg | beginning 20 min before the start of surgery until 20 min after the surgery. | 
| Heart rate | HR; beats per min [bpm] | beginning 20 min before the start of surgery until 20 min after the surgery. | 
| Cardiac index | CI; L/[min·m2] | beginning 20 min before the start of surgery until 20 min after the surgery. | 
| Systemic vascular resistance index | SVRI; [dyn·s]/[cm-5·m2] | beginning 20 min before the start of surgery until 20 min after the surgery. | 
| Global end-diastolic volume index | GEDVI; mL/m2 | beginning 20 min before the start of surgery until 20 min after the surgery. | 
| Leukocyte subset analysis | 10^3/ul | preoperation till 5 days after surgery | 
| Intracellular oxidative activity of neutrophils | ratio compared with preoperation | preoperation till 5 days after surgery | 
| Inducible nitric oxide synthase expression in monocytes | Arbitrary intensity | preoperation till 5 days after surgery | 
| Interleukin-6 | pg/ml | preoperation till 5 days after surgery | 
| C-reactive protein | ng/ml | preoperation till 5 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracoscopic surgery