EUCTR2005-002741-39-DK进行中（未招募）不适用
A prospective, controlled, randomized, patient and evaluator blinded study to evaluate pain and further disabling complications in patients undergoing Lichtenstein technique for primary inguinal hernia repair by fixing the mesh with TISSUCOL/TISSEEL fibrin sealant versus sutures. - TIMELI 001
niversità di Milano, Dipartimento di Scienze Chirurgiche, Ospedale Maggiore Policlinico, Padiglione0 个研究点目标入组 328 人开始时间: 2006年2月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 328
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1.Written signed informed consent obtained from the subject prior to participation in the study.
- •2.Active males over the age of 18 years and till 70 years. Active is defined by having normal daily activities.
- •3.Experiencing an uncomplicated unilateral primary inguinal hernia.
- •4.Subjects eligible for elective inguinal hernia repair using Lichtenstein technique.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Recurrent, bilateral, scrotal, incarcerated or femoral hernias.
- •2.Hernia types L3 and M3 according the European Hernia Society classification assessed pre or intra-operatively
- •3.BMI equal or more than 35
- •4.Concomitant abdominal surgery
- •5.Ongoing long term analgesic or steroid treatment
- •6.Patients under Clopidogrel or Warfarin (can be switched to LMW sub-cutaneous heparin)
- •7.Known abuse of alcohol or drugs
- •8.Liver cirrhosis (Child C)
- •9.Hypersensitivity to bovine aprotinin
- •10.Known immunodeficiency
- •11.Severely compromised physical or psychological health, that in the investigator’s opinion will affect patient’s compliance
- •12.Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
研究者
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