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2006年1月2日
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- nilateral, uncomplicated primary inguinal hernia repair
- 发起方
- Pr Giampiero CAMPANELLI Università di Milano, Dipartimento di Scienze Chirurgiche, Ospedale Maggior
- 入组人数
- 328
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
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
结局指标
主要结局
未指定
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