Clinical trial NCT02647775: Hemodynamic and Inflammatory Responses in Thoracic Surgery
Official title: Hemodynamic and Inflammatory Responses in Thoracic Surgery: Hemodynamic and Inflammatory Responses Following Video-assisted Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Video-Assisted Thoracic Surgery
Keywords: Thoracoscopic surgery
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 63
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Pain score
timeFrame: beginning at 3 hours after surgery until 5 days
Secondary outcomes:
measure: Complication
timeFrame: beginning at 3 hours after surgery until 30 days
measure: Mean arterial pressure
timeFrame: beginning 20 min before the start of surgery until 20 min after the surgery.
measure: Heart rate
timeFrame: beginning 20 min before the start of surgery until 20 min after the surgery.
measure: Cardiac index
timeFrame: beginning 20 min before the start of surgery until 20 min after the surgery.
measure: Systemic vascular resistance index
timeFrame: beginning 20 min before the start of surgery until 20 min after the surgery.
measure: Global end-diastolic volume index
timeFrame: beginning 20 min before the start of surgery until 20 min after the surgery.
measure: Leukocyte subset analysis
timeFrame: preoperation till 5 days after surgery
measure: Intracellular oxidative activity of neutrophils
timeFrame: preoperation till 5 days after surgery
measure: Inducible nitric oxide synthase expression in monocytes
timeFrame: preoperation till 5 days after surgery
measure: Interleukin-6
timeFrame: preoperation till 5 days after surgery
measure: C-reactive protein
timeFrame: preoperation till 5 days after surgery
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yun-Hen Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Hung-Pin Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Yi-Cheng Wu
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Ming-Ju Hsieh
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Wei-Hsun Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Yen Chu
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Chien-Ying Liu
role: PRINCIPAL_INVESTIGATOR
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