Case-control Study of Mesh-infection After a Size Tailored Hernia Repair With C-Qur V-Patch
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- mesh infection
研究概览
简要总结
Ventral hernias, such as umbilical, epigastric and trocar-site hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect. The SITUP-trial was a prospective cohort study who was designed to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects. The study was stopped prematurely because of the perception of an unacceptably high rate of mesh infection. This new study will retrospectively examine the incidence of mesh infection in all ventral hernias repaired with a C-QUR V-Patch. Collection of patient data was done using the Eura-HS registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •all adult patients that are planned for surgical repair of a umbilical, epigastric or trocar-site hernia will be considered to enter the study.
排除标准
- •patients refusing to participate at the follow up visits pregnancy age < 18 years life expectancy less than 12 months emergency operations liver cirrhosis or ascites cancer patients concomitant surgery other than hernia repair
结局指标
主要结局
mesh infection
时间窗: incidence over 12 months
次要结局
- hernia recurrence rate(incidence over 12 months)
研究者
Stijn De Sutter
Dr. Stijn De Sutter
Algemeen Ziekenhuis Maria Middelares
