EUCTR2005-002741-39-DE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 REPAIRBY FIXING THE MESH WITH TISSUCOL/TISSEEL FIBRIN SEALANT VERSUS SUTURES - TI.ME.LI. study
Pr Giampiero CAMPANELLI Università di Milano, Dipartimento di Scienze Chirurgiche, Ospedale Maggior0 个研究点目标入组 328 人开始时间: 2006年1月2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
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?
- •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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