NCT04109105Unknown不适用
Prospective Pilot Study for the Efficacy and Security Analysis in the Protection of Ileocolic Anastomosis Conducted in Laparoscopic Right Hemicolectomy Because of Colon Cancer, Using a Using a NHS-PEG (N-hydroxysuccinimide Functionalized Polyethylene Glycol) Coated Collagen Patch.
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Effectiveness and security analysis in the prevention of anastomosis leakage through the protection of ileocolic anastomosis with NHS-PEG coated collagen patch.
研究概览
简要总结
The aim of this study is to analyse the effectiveness and security in the prevention of anastomotic leakage by protecting the ileocolic anastomosis with a reabsorbable NHS-PEG collagen patch.
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
- •≥ 18 years old.
- •Ability to understand and make their own decision to participate in the study.
- •Pre-surgery right colon adenocarcinoma pathological diagnosis.
- •Patient with a mechanic, intra or extracorporeal ileocolic anastomosis.
排除标准
- •Urgent intervention.
- •Simultaneous colon cancer.
- •M1 pre-surgery staging.
结局指标
主要结局
Effectiveness and security analysis in the prevention of anastomosis leakage through the protection of ileocolic anastomosis with NHS-PEG coated collagen patch.
时间窗: Up to 30 days after the surgery
Ileocolic anastomosis leakage existence of evidence and seriousness.
次要结局
- Number of hospital readmissions.(Up to 30 days after the surgery)
- Number of complications related to anastomotic leakage in patients with ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.(Up to 30 days after the surgery)
- Analysis of the percentage of leaks in the ileocolic anastomosis reinforced with NHS-PEG coated collagen patch.(Up to 30 days after the surgery)
- Number of surgical repetitions.(Up to 30 days after the surgery)
研究者
研究点 (1)
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