Abdominal Wall Tension in Patients Undergoing Ventral Hernia Repair Without Component Separation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Abdominal wall tension in patients hernia repair without component separation
研究概览
简要总结
The purpose of this study is to use a scale to learn more about the tension of the abdominal wall in hernia repairs without component separation.
- What is the abdominal wall tension for hernias repaired without a component separation?
- What patient factors contribute to greater abdominal wall tension?
- Is there an association between abdominal wall tension before primary closure or bridging repair and patient outcomes?
Participants will be asked to allow their surgeon to use a tension scale to measure the tension of the abdominal wall during surgery.
详细描述
This is a prospective cohort study. Patients who undergo hernia repair without component separation will have their abdominal wall tension measured using a tension scale. The scale is an investigational (experimental) device that works by attaching to surgical clamps during surgery to measure the tension on the abdominal wall. The study operations will be performed at Cleveland Clinic by six hernia surgeons with advanced abdominal wall reconstruction training.
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
- 是
入选标准
- •Patients who are planned to undergo ventral hernia repair without component separation
- •Midline hernia
排除标准
- •Mesh excision for reasons other than mesh infection
- •Prior component separation
- •Isolated flank hernia
- •Patients under the age of 18 years
- •Pregnant patients
结局指标
主要结局
Abdominal wall tension in patients hernia repair without component separation
时间窗: 2 year
The abdominal wall tension prior to closure will be measured
次要结局
- Patient factors that contribute to greater abdominal wall tension(2 year)
- Association between abdominal wall tension and patient outcomes(2 year)
研究者
Benjamin T. Miller
Principal Investigator
The Cleveland Clinic