Intracorporeal Versus Extracorporeal Anastomosis After Laparoscopic Right Colectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- tumor necrosis factor alpha
研究概览
简要总结
The short-term advantages of minimally invasive colon resection have been well established in several randomized trials. A major factor in the development of morbidity is the surgical stress response with subsequent increased demand on the patient's reserves and immune competence. Although the advantage in term of stress response of laparoscopic surgery over open surgery has been widely reported, little is known about the role of Intracorporeal anastomosis.
In an attempt to evaluate the surgical stress response after totally laparoscopic right colectomy a comparative study has been designed.
Two surgical procedures will be evaluated:
- Totally laparoscopic right colectomy with intracorporeal anastomosis (Experimental group)
- Laparoscopic assisted right colectomy with extracorporeal anastomosis (Control group).
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All elective laparoscopic right colectomy for cancer
排除标准
- •Urgent procedures Immune depressant therapy Immune depressant disease Post-operative Complications
结局指标
主要结局
tumor necrosis factor alpha
时间窗: change between time before surgery, 24 hours after surgery, 72 hours after surgery
interleukin 6
时间窗: change between time before surgery, 24 hours after surgery, 72 hours after surgery
adrenocorticotropic hormone
时间窗: change between time before surgery, 24 hours after surgery, 72 hours after surgery
cortisol
时间窗: change between time before surgery, 24 hours after surgery, 72 hours after surgery
glucagon
时间窗: change between time before surgery, 24 hours after surgery, 72 hours after surgery
growth hormone
时间窗: change between time before surgery, 24 hours after surgery, 72 hours after surgery
interleukin 1
时间窗: change between time before surgery, 24 hours after surgery, 72 hours after surgery
insulin
时间窗: change between time before surgery, 24 hours after surgery, 72 hours after surgery
C-reactive protein
时间窗: change between time before surgery, 24 hours after surgery, 72 hours after surgery
prolactin
时间窗: change between time before surgery, 24 hours after surgery, 72 hours after surgery
fibrinogen
时间窗: change between time before surgery, 24 hours after surgery, 72 hours after surgery
次要结局
未报告次要终点
研究者
Marco Milone
Professor of Surgery (MD, PhD)
Federico II University