NCT05400083Unknown不适用
Prevention of Incisional Hernia With Biosynthetic Mesh at the Site of Temporary Ileostomy Closure
Federico II University1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2021年5月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Incisional hernia rate
研究概览
简要总结
Prophylactic mesh reinforcement of the abdominal wall at the site of temporary ileostomy closure is effective in preventing postoperative incisional hernia.
This prospective, multicenter, observational study will evaluate performance of Phasix biosynthetic mesh when used to reinforce fascial closure .
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
- •Subjects will be informed about the study, and will have read; understood and signed the informed consent
- •Subjects of either gender that are at least the age of 18 years
- •Subjects will be undergoing ileostomy reversal with retromuscular placement technique of the Phasix biosynthetic mesh reinforcement
排除标准
- •Subjects who, in the surgeon's opinion, would have a difficult time comprehending or complying with the requirements of the study
- •Subjects with parastomal hernia or midline incisional hernia
- •Subjects who required midline laparotomy during ileostomy reversal
结局指标
主要结局
Incisional hernia rate
时间窗: at 24 months
CT scan or Ultrasound as imaging to detect incisional hernia
次要结局
- Early and Long-term Complication Rates(after surgery to 24 months)
- Postoperative pain(after surgery to 24 months)
- Quality of life by Carolinas Comfort Scale (CCS) and Euro-Qol 5D-5L questionnaires(after surgery to 24 months)
- Budget Impact Analysis(after surgery to 24 months)
研究者
Umberto Bracale
Prof.
Federico II University
研究点 (1)
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