The Change in Tension of the Abdominal Wall Tension in Open Abdomens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in tension over time
研究概览
简要总结
The goal of this observational study is to quantitatively measure the change in tension of the abdominal wall over time in subjects with open abdomens using a tensiometer.
详细描述
For subjects undergoing damage control and decompressive laparotomy, surgeons frequently elect to keep the abdomen open in anticipation of multiple re-explorations or to prevent and/or treat abdominal compartment syndrome. The eventual goal is to definitively close the abdomen, including the fascia, when medically and surgically safe. The natural tendency with prolonged open abdomen is lateralization of the fascia, making closure of the fascia progressively more difficult as time passes. Though this is subjectively observed in the operating room as increased tension during fascial closure, there is no quantitative data describing how duration of open abdomen affects tension on the abdominal wall. This information has potential implications on the likelihood of successful primary closure, risk of dehiscence, and long term hernia development. This study aims to quantitatively measure the changes in tension of the abdominal wall over time in subjects with an open abdomen. A tensiometer will be used to measure the tension needed to approximate each side of the abdominal fascia to midline with each re-exploration until definitive abdominal wall closure.
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
- •Adult patients with an open abdomen and plan for abdominal re-exploration
排除标准
- •patients under the age of 18 years
- •pregnant patients
- •patients who have no available Legally Authorized Representative to provide consent.
- •patients with a current hernia
- •patients with a prior component separation
结局指标
主要结局
Change in tension over time
时间窗: 1.5 years
The progressive change in abdominal wall tension will be analyzed
次要结局
- Medical care factors affecting abdominal wall tension over time(1.5 years)
- Subject factors affecting abdominal wall tension over time(1.5 years)
- Operative factors affecting abdominal wall tension over time(1.5 years)
研究者
Benjamin T. Miller
Assistant Professor
The Cleveland Clinic
