NCT00842842已完成不适用
A Prospective, Controlled, Randomized, Patient and Evaluator Blinded Study to Evaluate Pain and Recovery in Patients Undergoing Laparoscopic Umbilical Hernia Repair by Fixing the Mesh With Tisseel Versus Tackers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 7
- 主要终点
- Postoperative pain VAS 0-100 mm
研究概览
简要总结
The purpose of this study is to determine whether mesh fixation in laparoscopic umbilical hernia repair with fibrin glue is superior to tacks in terms of postoperative pain and recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-85 years and Danish speaking
- •Umbilical hernia Ø 1.5 - 5 cm at preoperative clinical examination
- •ASA group I-III
排除标准
- •Former laparoscopic umbilical herniotomy
- •Incarceration
- •Drug/alcohol abuse/ongoing use of strong analgesic
- •Bad compliance
- •Liver disease Child-Pugh stage B/C
- •Immunodeficiency (ex. steroid use)
- •Pregnancy
- •Other hernias recognized perop. and operated on at the same operation
- •Lack of consent
结局指标
主要结局
Postoperative pain VAS 0-100 mm
时间窗: 1 year
次要结局
- QoL, SF-36, recurrence (safety)(1 year)
研究者
研究点 (7)
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