Is the Evaluation of Anal Distensibility by Endoflip® Technique Useful for the Diagnosis of Anismus?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Specificity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
研究概览
简要总结
Terminal constipation affects 13 to 20% of the french population. Anismus is defined by an absence of relaxation or a paradoxical contraction of the striated anal sphincter muscle during defecation.
Anismus is one of the main causes of terminal constipation. Anismus diagnosis is retained if 2 out of 3 examinations (manometry, electromyogram, defecography) are positive.
EndoFLIP® is a new medical device developed to measure distensibility of a hollow organ. Anal EndoFLIP® l could be a more sensitive and specific tool for detecting anismus in patients with distal constipation.
60 patients suffering from distal constipation will be included in order to perform, in addition to the usual examinations, an anal EndoFlip in order to test the sensitivity and specificity of this method for the diagnosis of anismus.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient older than 18 years
- •patient with distal constipation defined according to the Rome IV criteria, for at least 3 months and verified by a transit time study showing a predominant slowing of markers at the recto-sigmoid level.
- •patient who read and signed the informed consent form
排除标准
- •Patients with a predominant right of left colonic constipation;
- •Pregnant woman or woman with no effective contraception and of childbearing age
- •Patient with inflammatory bowel disease, ischemic colitis, history of colon or rectal cancer, infectious colitis or proctologic disease.
- •Patient with anorectal malformation
- •Patient with an history of pelvic floor radiotherapy
- •Patient with a digestive stoma
- •Insertion of the probe impossible or painful
- •Patient who has participated to a clinical trial within 30 days prior to the inclusion visit
- •Patient not understanding or reading French
- •Patients under guardianship, curatorship, safeguard of justice
- •Patient without liberty by administrative or judicial decision
结局指标
主要结局
Specificity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
时间窗: 30 min
Sensitivity of the anal distensibility evaluated with the EndoFLIP® technique for the diagnosis of anismus
时间窗: 30 min
次要结局
未报告次要终点