临床试验/NCT00393887

NCT00393887已完成不适用

Inguinal Hernia Study: A Double Blinded Randomized Prospective Study

Cook Group Incorporated2 个研究点分布在 1 个国家目标入组 100 人开始时间: 2007年3月最近更新: 2015年11月20日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Cook Group Incorporated
入组人数: 100
试验地点: 2
主要终点: Number of Patients With Inguinal Hernia Recurrence

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.

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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•18 years of age
•Diagnosis of Unilateral inguinal hernia repair
•Able to provide written consent

排除标准

•Incarcerated hernia
•Allergic or religious beliefs that disallow porcine material
•Previous hernia repair on the designated hernia site
•Class IV or V anesthesia requirements
•Bowel obstruction
•Peritonitis
•Life expectancy < 3 years

研究组 & 干预措施

1

Experimental

Biodesign IHM Graft placement

干预措施: Biodesign IHM (Device)

2

Active Comparator

Polypropylene mesh placement

干预措施: Polypropylene mesh (Device)

结局指标

主要结局

Number of Patients With Inguinal Hernia Recurrence

时间窗: 1 year

次要结局

未报告次要终点

研究者

发起方

Cook Group Incorporated

申办方类型

Industry

责任方

Sponsor

研究点 (2)

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