NCT01669837已完成不适用
Cyanoacrylate Fixation for Laparoscopic Repair of Inguinal Hernias: a Prospective, Multicenter Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Duomed
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Postoperative pain
研究概览
简要总结
Prospective, multicenter, observational registry to collect data of laparoscopic inguinal hernia repair using surgical tissue glue fixation. The objective is to determine the prevalence of chronic pain at 1 year.
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
- •Patient is older than 18 years.
- •Written informed consent is obtained from patient.
- •Patient is able to complete the EQ-5D questionnaire.
- •Patient has a primary unilateral or primary bilateral inguinal hernia- Mesh fixation is established with solely surgical tissue glue (Ifbond™).
排除标准
- •Patient has a recurrent inguinal hernia.
- •Patient is treated using the Lichtenstein technique.
- •Mesh fixation with sutures, tacks, absorbable tacks or clips.
- •Patient is allergic to components of surgical tissue glue (Ifbond™).
- •Patient has a life expectancy of less than 1 year.
结局指标
主要结局
Postoperative pain
时间窗: up to 1 year
Prevalence of postoperative pain evaluated by patient self-assessment using a visual analog scale.
次要结局
- Quality of life (QOL)(Preoperative, 5 weeks, 1 year)
- Intraoperative complications(1 day)
- Postoperative complications(Up to 30 days after index-procedure)
- Analgesic intake(Discharge, 5 weeks)
- Freedom from hernia-related reinterventions(1 year)
- Late complications(1 year)
研究者
研究点 (1)
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