Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 6
- 主要终点
- Prevalence of Inflammation as Diagnosed by Capsule Endoscopy
研究概览
简要总结
To show that prevalence of inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone.
详细描述
IBD of the small bowel is associated with perianal disease such as ano-rectal abscesses and fistulas. Colonoscopy with ileoscopy and small bowel series are relied upon to document the presence of Crohn's disease of the small bowel. We suspect that the prevalence of inflammatory small bowel disease is underestimated.
In my practice I have cases that had negative colonoscopy ileoscopy and positive findings at capsule endoscopy. These patients are receiving therapy for Crohn's disease. It is important to prove that the prevalence is higher.
Capsule Endoscopy (CE) is the "first line tool" diagnostic procedure for the examination of the small bowel. It is performed today in more than 2,900 GI clinics in hospitals, outpatient departments and physicians' offices all over the world using the PillCam® Platform. Over 500,000 CE procedures with the Given PillCam SB have been completed to date.
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
入排标准
- 年龄范围
- 10 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the ages of 10 - 80
- •Patients with anorectal abscess of anorectal fistula
- •Patient is male or female
- •Within three months prior to enrollment, patient has normal test results for at least one of the following tests:
- •Colonoscopy with Ileoscopy, and/or
- •Colonoscopy with small bowel series, and/or
- •Colonoscopy with CT enterography
- •Within three months prior to enrollment patient has the following lab tests: Blood count, sedimentation rate, CRP. IBD serology is optional.
- •Sign informed consent
排除标准
- •Can not sign informed consent
- •Contraindications to colonoscopy ileoscopy or capsule endoscopy
- •History of established IBD
研究组 & 干预措施
capsule endoscopy
patients eligible according to inclusion criteria who underwent a capsule endoscopy
干预措施: capsule endoscopy (Device)
结局指标
主要结局
Prevalence of Inflammation as Diagnosed by Capsule Endoscopy
时间窗: up to 7 days
The capsule endoscopy findings were carefully examined by specialists in the field. findings such as erosions, edema, erythema and ulceration in significant areas of the intestine led to the clinical diagnosis of crohn's disease. all together 6 patients were diagnosed as suffering from crohn's disease.
次要结局
未报告次要终点
研究者
Sam Adler
Prof. Samuel N. Adler, MD
Bikkur Holim Hospital