NCT02089958已完成不适用
Standardization of Laparoscopic Intraperitoneal Onlay Mesh Augmentation for Incisional Hernia Repair: Impact on Clinical Outcomes and Quality-of-Life - Open Prospective Observational Multicentre Cohort Study
Klinikum Fulda1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2013年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Recurrence rate
研究概览
简要总结
Incisional hernias are one of the most frequent complications in abdominal surgery. Laparoscopic repair is widely used but even not standardized. Existing data from different study designs show no representative data resulting in a lack of comparability and evidence. Therefore the standardization of operative techique has been proposed by the LIPOM-study group and will be assessed in a prospective manner.
详细描述
Data are scheduled for publication.
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
- •Primary incisional hernia
- •Hernia size EHS W 1-2
- •Hernia location EHS M 1-5, L 1-3
- •Clinical symptoms or progressive growth of hernia
排除标准
- •Recurrent incisional hernia
- •Ventral hernie
- •Hernia size > EHS W 2
- •Hernia location EHS L 4, ASA >3
- •Prospective mesh overlap < 5 cm
- •Malignant disease
结局指标
主要结局
Recurrence rate
时间窗: until 12 mths postoperatively
次要结局
- Pain, Quality of Life(until 12 mths postoperatively)
研究者
Achim Hellinger
Priv. Doz. Dr. med.
Klinikum Fulda
研究点 (1)
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