NCT02469142Unknown2 期
Use of Acellular Dermal in the Incarcerated Inguinal Hernia Tension-free Reconstructions
Xijing Hospital of Digestive Diseases1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- the recurrence rate after operation
研究概览
简要总结
Incarcerated inguinal hernia is one of the common acute abdomen abdominal surgery, often prone to intestinal necrosis and acute peritonitis.Using traditional tension hernia reparation, the recurrence rate were as high as 30%. In recent years, biological materials especially acellular matrix materials (Acellular Dermal Matrix, ADM) in resisting the infection, has become a research hotspot. In the project, the investigators try to address the role of ADM in incarcerated inguinal hernia patients.
详细描述
observation indicator:
- recurrence rate after operation
- incidence rate of complications
- postoperative hospital stay
- hospitalization costs
- Self-evaluation of gastroesophageal reflux symptoms and quality of life(QOL) in 6th-month, 1st-year,2nd-year,3rd-year,4th-year and 5th-year after operation
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
- None
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of incarcerated hernia
- •randomly select patch agreed by patients and family members
排除标准
- •severe organ dysfunction
- •No-tolerate anesthesia
- •No-suitable for operation
- •glucocorticoid with long-term use
- •Sever intraperitoneal adhesion existed
- •spirit disease patients
- •automatically exit
结局指标
主要结局
the recurrence rate after operation
时间窗: ten years
次要结局
未报告次要终点
研究者
Xiaonan Liu
Principal Investigator
Xijing Hospital of Digestive Diseases
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Use of Human Fibrin Glue Versus Staples for Mesh Fixation in Laparoscopic Transabdominal Preperitoneal HernioplastyHernia, InguinalNCT01641718Sascha Müller82
已完成
不适用
Study of Histological Findings of the Internal Inguinal Ring in Patients With Indirect Inguinal HerniaIndirect Inguinal HerniaNCT01211067Cirujanos la Serena72
进行中（未招募）
不适用
Incisional Hernia Repair by Abdominal Wall Component Release With Contemporary Onlay Mesh FixationOnlay MeshAbdominal Wall Component ReleaseIncisional HerniaNCT06178965Zagazig University17
撤回
1 期
A Study of Fibrin Sealant Plus Silver Microparticles to Prevent Incisional Hernias Following Abdominal SurgeryVentral HerniaAbdominal HerniaHerniaNCT02584153Hobart Harris
招募中
不适用
Biosynthetic Absorbable Mesh vs Standard of Repair for the Surgical Treatment of Infected Incisional HerniaVentral Hernia RepairNCT04597840Hospices Civils de Lyon108