The Impact of Abdominal Wall Reconstruction on Abdominal Wall Tension and Intra-Abdominal Pressure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Correlation between intra-abdominal pressure (mmHg) and rate of post-operative complications
研究概览
简要总结
This is a prospective cohort study. Patients have an incisional or parastomal hernia with >20 cm fascial defect on pre-operative imaging who will undergo an anticipated open bilateral transversus abdominis release with retromuscular synthetic mesh will have their abdominal wall tension measured using a tension scale and their intra-abdominal pressure measured using a urinary catheter containing pressure sensors. The investigators aim to quantify the changes, as well as explore and describe the physiologic shifts that may be associated with these changes.
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 ≥ 18 years of age
- •Incisional or parastomal hernia with >20 cm fascial defect on pre-operative imaging
- •Anticipated open bilateral transversus abdominis release with retro-muscular synthetic mesh placement
排除标准
- •Pregnant patients
- •Require a Legally Authorized Representative (LAR) to sign the informed consent form
结局指标
主要结局
Correlation between intra-abdominal pressure (mmHg) and rate of post-operative complications
时间窗: 1 year
Intra-abdominal pressure measured in mmHg using TraumaGuard catheter Post-operative complications measured in proportion of events
次要结局
- Correlation between intra-abdominal pressure (mmHg) to abdominal wall tension (lbs)(1 year)
- Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to hernia defect size (cm)(1 year)
- Correlation between abdominal wall tension (lbs) and intra-abdominal pressure (mmHg) to airway pressure (cmH2O)(1 year)
- Temporal changes in renal function (serum Creatinine)(1 year)
研究者
Benjamin T. Miller
Principal Investigator
The Cleveland Clinic