Prospective Cohort Study on Mesh Shrinkage Measured With MRI After Robot Assisted Laparoscopic Retromuscular Hernia Repair Using an Iron Oxide Loaded PVDF Mesh
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change of the 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 retromuscular incisional hernia repair with ipsilateral access and the use of the visible CICAT mesh (Dynamesh®) for defect repair. The investigators also want to measure the volume of the rectus muscles and the change between 1 and 13 months.
详细描述
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 retromuscular incisional hernia repair with ipsilateral access and the use of the visible CICAT mesh (Dynamesh®) for defect repair. The investigators also want to measure the volume of the rectus muscles and the change between 1 and 13 months. Possibly the ipsilateral retromuscular access could induce some atrophy of the rectus muscles.
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. Dr.Muysoms will inform all patients about the surgery and the follow-up with MRI scan thereafter. Dr. Beckers and Dr. Heindryckx 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.
The investigators want to show that with this type of mesh it is possible to visualize the mesh after retromusculare placement in vivo 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
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •20 patients selected and operated by PI.
排除标准
- •<18 years
- •Emergency surgery (incarcerated hernia)
- •Clean-contaminated, contaminated or dirty procedures (according to the CDC classification)
- •Lateral hernias
- •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 the 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
- Change in mesh surface between implantation surface size(1 month and 13 month post-operatively)
- Change in mesh width and length between implantation surface size(1 month and 13 month post-operatively)
- Operation duration(once during operation)
- Intra-operative complications(until 4 weeks post-operative)
- Volume of the rectus muscle at the level of the umbilicus(1 month and 13 month post-operatively)
- Early post-operative complications(until 30 days post-operative)
- Late complications(after 30 days post-operative)
- Quality of Life questionnaire(preoperative and 1 month and 13 month post-operatively)
研究者
Filip Muysoms
Surgeon
Algemeen Ziekenhuis Maria Middelares