Clinical Trial for the Determination of Advanced Colonic Neoplasia Prevalence and the Need for Colonoscopy in Complicated and Uncomplicated Acute Diverticulitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 313
- 试验地点
- 2
- 主要终点
- Presence of ACN
研究概览
简要总结
This study evaluate the prevalence of advanced colonic neoplasia (ACN) in acute diverticulitis. A sub-analysis of complicated and uncomplicated acute diverticulitis will be made in order to determinate whether there are differences of advanced colonic neoplasia (ANC) prevalence in both groups and to assess if a colonoscopy is necessary.
详细描述
This is a prospective study that eliminates biases in the selection, design and variability of retrospective studies to reliably assess the global prevalence of advanced colon neoplasia (ACN) and the difference in prevalence among populations with complicated and uncomplicated acute diverticulitis diagnosed by computed tomography. Another objective is to assess the diagnostic prediction of computed tomography to detect ACN in acute diverticulitis. It also aims to assess the safety and quality of colonoscopy in a patient recently diagnosed with acute diverticulitis. Finally, it aims to study whether other diagnostic tools such as the presence of clinical risk symptoms or the performance of fecal biological tests could help in narrowing the indication of colonoscopy in this clinical scenario.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients consecutively diagnosed with acute diverticulitis in the participating hospitals during the study inclusion period will be included. For this purpose, a multidetector computerized tomography confirming the diagnosis of acute diverticulitis must be performed on all patients with initial clinical suspicion.
排除标准
- •Patient refusal to participate in the study.
- •Impossibility of obtaining informed consent by the patient or guardian.
- •Age <18 years and> 85 years
- •Impossibility of performing a diagnostic CT of AD.
- •Intercurrent medical or surgical process with prolonged recovery in time that prevents a colonoscopy before 6 months after the resolution of the episode of acute diverticulitis.
结局指标
主要结局
Presence of ACN
时间窗: At the moment of colonoscopy.
For our study, ANC is all colonic lesions that are advanced adenoma or colorectal cancer. Advanced adenoma is defined as that adenoma with size\> 10mm, villous component in\> 25% and / or high-grade dysplasia or all serrated lesions\> 10mm with or without dysplasia. Colonoscopy is the gold standard for ANC detection.
次要结局
- Clinical symptoms predictive value for ANC detection(At the moment of colonoscopy.)
- Fecal calprotectin test predictive value for ANC detection(At the moment of colonoscopy.)
- CT predictive value for ACN detection(At the moment of colonoscopy.)
- Colonoscopy quality(At the moment of colonoscopy.)
- FIT predictive value for ANC detection(At the moment of colonoscopy.)
- Colonoscopy security(30 days post-colonoscopy.)