NCT04811833撤回不适用
Assessment of MonoPlus® Suture Material for Anastomosis in the Gastrointestinal Tract. A Prospective, Multi-centric, International, Single-arm, Observational Study in Daily Practice
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Aesculap AG
- 试验地点
- 2
- 主要终点
- Comparison of anastomosis leakage rate at different timepoints in postoperative course
研究概览
简要总结
The primary aim of this study is to collect clinical data on the performance of MonoPlus® suture applied in routine clinical practice. Diverse parameters are to be used to assess the safety and efficacy of MonoPlus® suture for gastrointestinal anastomosis construction.
This study has been designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Comparison of anastomosis leakage rate at different timepoints in postoperative course
时间窗: until 6 months after surgery
The primary endpoint of this study is the anastomosis leakage rate until 6 months after surgery
次要结局
- Comparison of Postoperative Obstipation at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery)
- Assessment of suture material handling parameters(intraoperatively)
- Comparison of dehiscence rate of the suture line at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month and 6 months after surgery.)
- Comparison of bleeding at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery)
- Comparison of Postoperative Fistula at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery)
- Comparison of the Peritonitis rate at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery)
- Comparison of Abscess at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery)
- Comparison of Postoperative Perforation at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery)
- Comparison of Postoperative Stenosis at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery)
- Length of the overall postoperative hospital stay(until discharge (approximately 10 days postoperative))
- Comparison of the Surgical Site infection rate at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery)
- Comparison of Reoperation rate due to an anastomosis leakage at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery)
- Comparison of Mortality rate at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery)
- Comparison of Stoma rate at different timepoints in postoperative course(at discharge (approximately 10 days after surgery), 1 month, and 6 months after surgery)
- Satisfaction of the patient with the surgery(at discharge (approximately 10 days postoperative), 1 month, and 6 months after surgery)
- Length of the postoperative stay in intensive care unit(until discharge (approximately 10 days postoperative))
- Duration to perform the anastomosis(intraoperatively)
- Course of Health Status(until 6 months postoperative)
研究者
研究点 (2)
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