Effect of an Adhesion Reduction Plan on Enteric Adhesions, Obstruction, and Fistulae in the Management of the Surgical Open Abdomen: A Prospective, Randomized Clinical Trial in Trauma and Emergency General Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Extent and severity of adhesions
研究概览
简要总结
The purpose of this study is to determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.
详细描述
Adhesions are a common consequence of abdominal surgery. Trauma and emergency general surgery patients may require an open abdomen and undergo a series of abdominal operations, which may be increasingly complicated by the presence of adhesions. Adhesions appear soon after the initial operation and gradually mature within days. The effects of adhesion development on subsequent surgery may include: increased procedure time; difficulty differentiating, exposing, and accessing tissue planes; and increased risk of inadvertent enterotomy. Complications of adhesions include enteric obstruction and enterocutaneous fistulae. This study will determine whether an adhesion reduction plan, consisting of early adhesion prevention and application of a bioresorbable membrane is effective in reducing the extent and severity of adhesions and the incidence of complications in managing the open abdomen in trauma and emergency general surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Trauma patients with open abdomen after initial laparotomy
- •Emergency surgery patients with open abdomen after initial laparotomy
- •Able to obtain consent from patient or LAR before any research initiated
排除标准
- •Seprafilm application at initial laparotomy
- •Patient is a prisoner
- •Inability to obtain informed consent
- •Consentable person does not speak English
研究组 & 干预措施
Adhesion Reduction Plan
Lysis of adhesions and application of Seprafilm
干预措施: Adhesion Reduction Plan (Procedure)
Standard Management
Standard management and no application of Seprafilm
结局指标
主要结局
Extent and severity of adhesions
时间窗: Each abdominal re-entry and re-exploration
次要结局
- Incidence of complications(Hospital admission)
- Time for lysis of adhesions(Each abdominal re-entry and re-exploration)
研究者
William Chiu
Associate Professor of Surgery
University of Maryland, Baltimore
