NCT03312569已完成不适用
A Multi-Center Prospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 306
- 试验地点
- 4
- 主要终点
- Incidence of incisional hernia at one year after index procedure.
研究概览
简要总结
To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies
详细描述
This is a prospective multicenter observational study to evaluate outcomes of intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject is 18 years or older
- •Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease
- •Subject undergoing intracorporeal or extracorporeal anastomosis proximal to mid-transverse colon
排除标准
- •Subject is contraindicated for general anesthesia or surgery
- •Emergent Case
- •Subject has perforated, obstructing or locally invasive neoplasm (T4b)
- •Subject with inflammatory bowel disease
- •Subject with prior incisional hernia repair
- •Planned right colectomy along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
- •Metastatic disease with life expectancy of less than 1 year
- •Pregnant or suspect pregnancy
- •Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
- •Subject belonging to other vulnerable population, e.g, prisoner or ward of the state
结局指标
主要结局
Incidence of incisional hernia at one year after index procedure.
时间窗: 1 year
The primary endpoint of the study is the incidence of incisional hernia for intracorporeal and extracorporeal anastomoses within one year after the right colectomy procedure. Incidence of incisional hernia either patient self-reported or clinical diagnosis will be assessed at one year after the right colectomy procedure.
次要结局
- Time to first flatus after index procedure(up to 1 week after index procedure)
研究者
研究点 (4)
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