NCT01877122已完成4 期
Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair
Samyang Biopharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2013年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- pain score (10-point Visual Analogue Scale)
研究概览
简要总结
Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of life)of two devices at 3 months follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patients >=20 years =<85 years old
- •Patients with Unilateral hernia
- •Patients without previous operations in lower part of abdomen
- •Patients capable to understand the explanation about purpose and method of the trial, and write an Informed Concent Form
- •Patients capable to participate during the period of the trial
排除标准
- •Previous hernia repair at the same site
- •Incarcerated hernia
- •Strangulated hernia
- •Patients to whom and open surgery cannot be indicated
- •Previous urological surgery
- •Immune incompetence of patient: AIDS, vesical fibrosis, etc.
- •Patients with AIHD or patients who take immunosuppressive drugs
- •Patients with liver disease (ASL, AST ≥ normal value by more than 3 times)
- •Patients with kidney disease (creatinine>2.0mg/dL)
- •Patients on anti-coagulants
- •Patients with severe systematic disease
- •Patients with malignant tumor
- •Patients with infection or with the predicted problem of surgery site healing
- •Participation in another clinical study within the last 30 days
- •Patients whose participation is considered inappropriate according to other except above mentioned clinical condition
结局指标
主要结局
pain score (10-point Visual Analogue Scale)
时间窗: Day90 after operation
次要结局
未报告次要终点
研究者
研究点 (1)
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