跳至主要内容
临床试验/NCT01010464
NCT01010464撤回不适用

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

University of Maryland, Baltimore1 个研究点 分布在 1 个国家开始时间: 2011年1月1日最近更新:
适应症
干预措施

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

Experimental

Lysis of adhesions and application of Seprafilm

干预措施: Adhesion Reduction Plan (Procedure)

Standard Management

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

William Chiu

Associate Professor of Surgery

University of Maryland, Baltimore

研究点 (1)

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