Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- The rate of anastomotic leakage.
研究概览
简要总结
The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures.
Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
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 was > 18 years old at time of procedure
- •Patient underwent a technically successful open or laparoscopic colorectal, Low Anterior Resection procedure with the creation of an anastomosis using the ColonRing™
- •Patient treated in routine clinical practice
- •Patient underwent his/her first follow-up visit within two months post-surgery
排除标准
- •No exclusion criteria have been defined for this data collection.
结局指标
主要结局
The rate of anastomotic leakage.
时间窗: 6 weeks after the procedure
Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.
次要结局
- Rate of other device related complications and measures during hospitalization and post procedure.(6 weeks after the procedure.)