Interest of Pan Capsule (Small Bowel and Colon Video Capsule) in Symptomatic Patients Suspected of Irritable Bowel Syndrome Requiring Colonoscopy Phase A Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Number of patients with digestive pathology and / or significant gastrointestinal lesion.
研究概览
简要总结
Irritable bowel syndrome (IBS) is a chronic disease characterized by the association of abdominal pain and transit disorders. IBS affects 5 to 10% of the population. There are several forms of IBS: IBS-D (with predominant diarrhea), IBS-C (with constipation predominant) and IBS-M (mixed with alternating diarrhea and constipation). In the absence of a diagnostic test to confirm the existence of this syndrome, the diagnosis of IBS is based on clinical criteria (Rome IV criteria). In patients suspected of IBS, especially in patients with diarrhea (IBS-D or IBS-M), a colonoscopy with biopsies is often proposed in addition to biological tests (Complete Blood Count, C-reactive protein, thyroid stimulating hormon and anti-transglutaminase antibodies) by the physician or gastroenterologist to exclude an organic digestive disease such as celiac disease, IBD (Crohn's disease or ulcerative colitis), microscopic colitis or even neoplasia.
The colonoscopy is an invasive exploration and does not allow exploration of the entire small bowel.
The development of capsules allowed the exploration of the small bowel more recently of the colon. The new developed pan-capsule allows evaluation of both small bowel and colon.
The aim of this work is to evaluate in patients younger than 50 years, presenting suspicious digestive symptoms of IBS with diarrhea, the interest of a strategy based on the pan-capsule as an alternative to colonoscopy to eliminate a diagnosis of organic digestive disease (celiac disease, IBD, neoplasia, ..).
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female: Age ≥ 18 years and ≤ 50 years
- •Patients with symptoms compatible with IBS-D or IBS-M according to the treating physician.
- •Indication for colonoscopy according to the physician
- •Absence of prior colonoscopy
- •Patient affiliated to a social security Insurance
- •Signature of signed informed consent.
排除标准
- •Functional or organic disorders of swallowing.
- •Dysphagia or suspicion of digestive stenosis.
- •Known Zenker Diverticule.
- •Major surgical history of the digestive tract (exclusion of appendectomy, cholecystectomy, surgery of hemorrhoids).
- •Known illness that could explain digestive symptoms.
- •Symptoms suggestive of occlusion.
- •Alteration of the general state and / or dehydration.
- •Chronic uncontrolled disease.
- •Disorders of consciousness.
- •Uncontrolled heart disease: myocardial infarction in the last 6 months, anginal disease status, NYHA grade III and above congestive heart failure, ventricular tachycardia, ventricular fibrillation, severe heart block.
- •Patient with a pacemaker or other implantable electronic medical device.
- •Polyethylene glycol allergy.
- •Oral iron intake in the four days preceding the video capsule.
- •Pregnant or lactating woman, woman of childbearing age who has not performed a pregnancy test, women and men of childbearing potential without effective contraception.
- •Impossible follow up for psychological or geographical reasons.
- •Patient under safeguard of justice.
- •Patient under guardianship or curatorship.
- •Simultaneous participation in another clinical study.
结局指标
主要结局
Number of patients with digestive pathology and / or significant gastrointestinal lesion.
时间窗: 1 month
Number of patients with digestive pathology and / or significant gastrointestinal lesion (mucosal atrophy, mucosal erythema or ulceration, inflammatory bowel disease, neoplasia: colon adenocarcinoma, polyps\> 5 mm, microscopic colitis).
次要结局
- Acceptability to complete the questionnaires (number of completed questionnaires).(1 month)
- Acceptability of the pan-capsule, preference of one of the carried out explorations (pan-capsule or iléo-colonoscopy).(1 month)
研究者
Robert Benamouzig
Professor, MD, PhD
Hospital Avicenne