Sensitivity and Predictive Value of Functional Cine Magnetic Resonance Imaging (MRI) Detecting Intra-abdominal Adhesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- Sensitivity and specificity
研究概览
简要总结
Official title:
Sensitivity and predictive value of functional cine magnetic resonance imaging (MRI) detecting intra-abdominal adhesions
Background:
Adhesions are a frequent problem in abdominal surgery. The formation of adhesions is part of a normal wound healing. However in some patients adhesions cause severe complications such as chronic pain, obstruction and strangulation of the bowel. Adhesions can also obstruct access to the peritoneal cavity and complicate reoperations. Accurate imaging of adhesions would be of benefit avoiding adhesion related complications at repeated laparotomy or laparoscopy. At present no validated diagnostic tool mapping adhesions exists.
Purpose:
To define the sensitivity and specificity of functional cineMRI in detecting and mapping adhesions in patients undergoing reoperation.
Design:
Prospective multicenter observational trial
Primary outcome:
Sensitivity and specificity of functional MRI detecting adhesions to the abdominal wall
Secondary outcome:
Sensitivity and specificity of functional MRI detecting organ-to-organ adhesions.
Estimated enrollment: 100
Estimated study completion date: dec 2019
Estimated primary completion date: dec 2019
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
- 否
入选标准
- •Patients with a median abdominal scar due to a previous open abdominal surgical procedures with a length of at least 10 cm and have given written consent.
排除标准
- •Severe claustrophobia.
- •No MRI allowed
结局指标
主要结局
Sensitivity and specificity
时间窗: 2 weeks
diagnsotic accuracy for detecting adhesions
次要结局
未报告次要终点