Hemodynamic and Inflammatory Responses in Thoracic Surgery: Hemodynamic and Inflammatory Responses Following Video-assisted Thoracoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Pain score
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with thoracic surgical diseases(lung cancer. mediastinal tumor. solitary pulmonary lesion. pneumothorax) who will be underwent video-assisted thoracic surgery
排除标准
- •Unresectable mediastinal tumor
- •Previous history of ipsilateral pulmonary resection
- •Patients with complex cardiopulmonary dysfunction
- •Unresectable pulmonary hilar tumor
结局指标
主要结局
Pain score
时间窗: beginning at 3 hours after surgery until 5 days
Numerical Rating Scale (NRS) or Wong-Baker Face Pain Rating Scale
次要结局
- C-reactive protein(preoperation till 5 days after surgery)
- Mean arterial pressure(beginning 20 min before the start of surgery until 20 min after the surgery.)
- Inducible nitric oxide synthase expression in monocytes(preoperation till 5 days after surgery)
- Cardiac index(beginning 20 min before the start of surgery until 20 min after the surgery.)
- Complication(beginning at 3 hours after surgery until 30 days)
- Systemic vascular resistance index(beginning 20 min before the start of surgery until 20 min after the surgery.)
- Global end-diastolic volume index(beginning 20 min before the start of surgery until 20 min after the surgery.)
- Intracellular oxidative activity of neutrophils(preoperation till 5 days after surgery)
- Interleukin-6(preoperation till 5 days after surgery)
- Heart rate(beginning 20 min before the start of surgery until 20 min after the surgery.)
- Leukocyte subset analysis(preoperation till 5 days after surgery)