The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension and Abdominal Compartment Syndrome.
试验速览
- 阶段
- 不适用
- 入组人数
- 42
- 主要终点
- Intra abdominal hypertension
研究概览
简要总结
This is a prospective comparison trial. Patients that will be included in the trial are those that will have operations in which their abdominal closure is temporary, i.e. patients sustaining trauma or septic abdomen.
Patients will be grouped according to the method of temporarily abdominal closure (TAC) procedure:
- Vacuum-assisted closure (VAC)
- "Bogota bag" (BB), a sterile intravenous bag silo closure. The two methods are currently accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center the decision to choose either of the methods is at the surgeon's discretion.
Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done as part of the monitoring processes of critically ill patients in the General Intensive Care Unit (GICU).
Patients will be evaluated for the development of acute intra abdominal hypertension with or without abdominal compartment syndrome.
详细描述
Comparison of intra-Abdominal hypertension development after bogota bag or VAC abdominal closure Protocol
Trial objective:
To investigate and compare in a standardized manner the development of intra-abdominal hypertension (IAH) following VAC closure and "Bogota bag".
Study design:
This is a prospective comparison trial. Patients that will be included in the trial are those that will have operations in which their abdominal closure is temporary, i.e. patients sustaining trauma or septic abdomen.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults male or female over 18 year old undergoing emergency laparotomy. Patients that have their abdominal wall closed at the end of surgery by a temporary closure technique.
排除标准
- •Patients that according to the surgeon estimates will not survive 24 hours.
结局指标
主要结局
Intra abdominal hypertension
时间窗: 48 hours
measured via a Foley catheter
次要结局
- Abdominal compartment syndrome(48 hours)
研究者
Gad Shaked MD
Professor
Soroka University Medical Center