Prospective Cohort Study on Mesh Shrinkage Measured With MRI After Robot Assisted Laparoscopic Preperitoneal Mesh Repair Using an Iron Oxide Loaded PVDF Mesh
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of mesh surface (percentage)
研究概览
简要总结
The aim of this study is to measure the mesh shrinkage and the visualization of the mesh with MRI scan at 1 month and 13 months after robot assisted preperitoneal hernia repair using the visible CICAT mesh (Dynamesh®).
详细描述
The study will be conducted in the department of surgery in het AZ Maria Middelares, Ghent, Belgium. Dr. Filip Muysoms will personally select and operate all patients eligible for this study. He will inform all patients about the surgery and the follow-up with MRI scan thereafter. Dr. Beckers will perform all MRI examinations of the patients at 1 month and 13 months post-operatively and will be available for questions from the patient.
We want to show that with this type of mesh it is possible to visualize the preperitoneal placed mesh in a safe manner. Furthermore, the positioning of the mesh, mesh shrinkage or mesh shifting will be monitored with this technique. This provides long-term benefit and provides early treatment possibilities in case of post-operative complications related to the mesh position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Primary umbilical hernias up to 2 cm
- •Incisional hernias limited to zone M3 (EHS classification) and smaller than 2 cm
排除标准
- •<18 years
- •Emergency surgery (incarcerated hernia)
- •Clean-contaminated, contaminated or dirty procedures (according to the CDC classification)
- •Lateral hernias
- •Hernias close to the sternum or the pubic bone
- •Hernias bigger than 2 cm in diameter.
- •Hernias that need a component separation technique.
- •Previous mesh repair on the midline
- •ASA score> 4
- •Pregnancy
- •No patient Informed Consent
- •Life expectancy of less than 2years
- •Contraindications for MRI
结局指标
主要结局
Change of mesh surface (percentage)
时间窗: 1 month and 13 month post-operatively
Shrinkage rate / change of the mesh surface (percentage) as measured with the MRI between 1 month and 13 months postoperatively, defined as (100 - mesh surface at 13 months x 100 / mesh surface at 1 month)
次要结局
- Late complications(After 30 days post-operative)
- Change in mesh surface between implantation surface size(1 month and 13 month post-operatively)
- Intra-operative complications(until 4 weeks post-operative)
- Change in mesh width and length between implantation surface size(1 month and 13 month post-operatively)
- Early post-operative complications(until 30 days post-operative)
- Body image score(Preoperatively, 30 days, 13 months)
- Operation duration(once during operation)
- Quality of Life questionnaire(Preoperatively, 30 days, 13 months)
研究者
Maaike Vierstraete
Medical Doctor Department General Surgery
Algemeen Ziekenhuis Maria Middelares