Diagnostic Accuracy of Ultrasonography and Computed Tomography in the Diagnosis of Mild-moderate Acute Diverticulitis: Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Number of partcipants dignosed of having acute diverticulitis by Computerized Tomography
研究概览
简要总结
Acute diverticulitis (AD) is the most common complication of diverticulosis and is divided into mild-moderate and complicated. Imaging methods are needed for its diagnosis, prognostic classification and therapeutic management. Currently the "gold-standard" imaging technique is computed tomography (CT) and most guidelines recommend it to classify and identify those patients with risk of treatment failure.
In this styudy, a prospective comparison of CT and abdominal ultrasound is proposed, with the aim of evaluating the diagnostic accuracy of ultrasound. An accurate ultrasound classification of AD would allow the differentiation of mild-moderate and complicated DA, avoiding routine CT and, therefore, patient's x-ray exposure.
详细描述
Study design, setting and patients. Pragmatic prospective cohort study comparing the diagnostic accuracy of US and CT scan.
During a 17-month period patients referred to the imaging department with a clinical suspicion of acute LCD will be evaluated with US and CT.
Following the hospital care protocol, patients with suspected uncomplicated LCD will first undergo an abdominal US examination. Immediately after US examination, patients will be evaluated with CT.
In emergency cases in which complicated diverticulitis is suspected, the study will start with a CT, followed by ultrasound.
The interval between both exploration test will be in all cases less than 1 hour and will be performed before the administration of any anti-inflammatory or antibiotic treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The two imaging examinations will be done by different radiologists blinded for the previous results.
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
- •Clinical suspicion of acute diverticulitis
排除标准
- •Hemodynamic instability that prevents a diagnostic delay
- •Pregnant patients
- •Previous history of allergy to iodinated contrast
结局指标
主要结局
Number of partcipants dignosed of having acute diverticulitis by Computerized Tomography
时间窗: First day of admission
Identical imaging criteria for the diagnosis of acute diverticulitis will be used used , regardless of the image technique (US or CT).
Number of partcipants dignosed of having acute diverticulitis by Ultrasonography
时间窗: First day of admission
Identical imaging criteria for the diagnosis of acute diverticulitis will be used used , regardless of the image technique (US or CT). Following the Neff modified classification, the minimum findings to take in to account will bethe presence of diverticula and mural thickening, alone or associated with inflammation of the pericolic fat (Stage 0). Mural thickening will be considered when colonic wall has 4mm or more. Other findings will be: localized pneumoperitoneum depicted by air bubbles (Stage Ia), and abscess \< 4cm (Stage Ib). Stage Ia and Ib will be considered as locally complicated diverticulitis. Findings considered as belonging to complicated diverticulitis will be: pelvic abscess \> 4cm (Stage II), an intra-abdominal abscess outside the pelvis (Stage III), or difuse pneumoperitoneum and intra-abdominal free liquid (Stage IV).
次要结局
- Need of surgical operation(During admission)
- Need of a secong evaluation by diagnostic imaging (ultrasonography or computerized tomography)(During admission)
研究者
Josep Maria Badia
Prof
Hospital de Granollers