NCT01141335已完成4 期
Lichtenstein's Repair of Inguinal Hernia With Polypropylene Mesh Versus Infinit® PTFE Mesh, a Prospective Randomized, Double-blind, Controlled Trial
University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2009年9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
- 70
- 试验地点
- 2
- 主要终点
- post-hernioplasty acute pain
研究概览
简要总结
To evaluate the safety and efficacy of the Lichtenstein's hernioplasty using Infinit® PTFE Mesh, and to compare it with the traditional Lichtenstein procedure performed with polypropylene mesh.
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 <65 years of age
- •Diagnosis of Unilateral inguinal hernia
- •Able to provide written consent
- •BMI < 35
- •ASA I-II patients
- •Non-complicated primary inguinal hernia performed in non-emergency setting and repaired with a Lichtenstein's hernioplasty
- •Informed consent
排除标准
- •Recurrent hernias
- •Incarcerated hernia
- •BMI > 35
- •ASA III-IV patients
- •Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient, drug addicted)
- •Hypersensitivity to any drug in study
- •Patients with an intra-operative findings of different pathology will be excluded from the study
结局指标
主要结局
post-hernioplasty acute pain
时间窗: 24 hours
to measure the degree of post-hernioplasty acute and chronic pain with visual analogue scale (VAS), and parenteral/oral analgesic consumption in the two groups
次要结局
- physical function(5 years)
- wound infection(5 years)
- postoperative acute discomfort(14 days)
- mesh shrinkage(5 years)
- post-hernioplasty chronic pain(5 years)
- postoperative acute and chronic discomfort(7 days)
- post-hernioplasty acute pain(14 days)
- recurrence(from 1 months to 5 years)
- postoperative complication(from 24 hours to 5 years)
- postoperative chronic discomfort(5 years)
研究者
Francesco Saverio Mari
MD
University of Roma La Sapienza
研究点 (2)
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