NCT04175756已完成不适用
CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery. An Observational, Prospective, Post-marketing Clinical Follow-up Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesculap AG
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Total operative time
研究概览
简要总结
This voluntary study is part of a Post-Market-Surveillance plan to proactively collect clinical data for the use of Caiman 5 articulating Maryland in colorectal surgery under daily clinical routine.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patient´s written informed consent
- •Planned laparoscopic colorectal cancer surgery using Caiman 5 articulating Maryland (according to the IfU)
- •Age ≥18 years
排除标准
- •Emergency surgery
- •Pregnancy
- •Participation in another surgical study, which might influence the intraoperative process
- •Conversion to open surgery
- •Conversion to another sealing / cutting instrument (instead of Caiman 5 articulating Maryland)
结局指标
主要结局
Total operative time
时间窗: intraoperatively
Time between first incision and closure of the surgical incision
次要结局
- Time needed for CME(Intraoperative)
- Time needed for TME(Intraoperative)
- First postoperative stool(up to discharge (approximately 10 days postoperative))
- Complications(up to 4 months postoperative)
- Time needed for PME(Intraoperative)
- Time needed for right / hepatic colic flexure mobilization(Intraoperative)
- Handling characteristics(intraoperative)
- First postoperative oral intake(up to discharge (approximately 10 days postoperative))
- Estimated intraoperative blood loss(intraoperative)
- Time needed for left / splenic colic flexure mobilization(Intraoperative)
- Stay in intensive care unit postop(up to discharge (approximately 10 days postoperative))
- Quality of excision: M.E.R.C.U.R.Y. criteria(up to discharge (approximately 10 days postoperative))
- Stay in intermediate care unit stay postop(up to discharge (approximately 10 days postoperative))
研究者
研究点 (1)
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