NCT01453556Unknown不适用
Intracorporeal Versus Extracorporeal Mechanical Anastomosis in Laparoscopic Right Colectomy. A Prospective Randomized Controlled Clinical Trial
Scientific Institute San Raffaele2 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2011年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Post-operative canalisation time and length of stay
研究概览
简要总结
Verify with a prospective randomised trial if intracorporeal mechanical anastomosis in laparoscopic right colectomy reduces post-operative bowel canalisation time and length of stay in comparison with extracorporeal mechanical anastomosis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or more
- •Benign o neoplastic disease of right colon
- •Elective laparoscopic surgery
排除标准
- •Emergency surgery
- •Adhesion or infiltration of near organs
- •Severe heart disease ( New York Heart Association class > 3 )
- •Severe respiratory disease ( arterial PO2 < 70 torr )
- •Severe Liver disease (Child-Pugh class C)
- •Ongoing infections
- •Number of plasmatic neutrophil < a 2.0 x 10 9/L
- •Other contraindications to laparoscopy
结局指标
主要结局
Post-operative canalisation time and length of stay
时间窗: Post-operative stay (about 7 days)
Comparison of post-operative bowel movement time (fist flastus and first dejection) and overall length of stay between the two study groups
次要结局
- Impact of post-operative ileum and complications. Valuation of global costs(12 months)
研究者
Andrea Vignali
Principal Investigator
Scientific Institute San Raffaele
研究点 (2)
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