Usefulness of High Resolution Manometry in Constipation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 3
- 主要终点
- Frequency of isolated propagated colonic contractions
研究概览
简要总结
Constipation is a frequent symptom that is reported by more than 10% of the general population. In a few case, constipation is resistant to medical standard care, including osmotic and stimulant laxatives. The diagnosis of colonic inertia may be suspected in these patients although diagnostic criteria for colonic inertia may vary from one country to another. In France, the diagnosis of colonic inertia is based on manometric study of the colorectal contractile activity using manometric probe. Using conventional manometric catheters, severe alteration of the colorectal motility is found in a very small subset of patients, who may later benefit from surgery. The recent use of high resolution manometric probe allowed to map more precisely colorectal motility, but whether these new parameters are relevant remains to be assessed. The aim of this study is to assess the diagnostic performance of a new high resolution manometric probe by comparing healthy volunteers to patients suspected of colonic inertia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •For patient
- •Inclusion Criteria:
- •Age between 18 and 65 years
- •chronic Constipation (> 6 months)
- •delayed colonic transit time > 100 h
- •normal colonoscopy
- •constipation refractory to at least 1 osmotic and 1 stimulant laxative according French guidelines on constipation ;
- •Affiliated to French national healthcare insurance
排除标准
- •Patient with constipation being either:
- •With colonic transit time <100h
- •Distal (with radio-opaque markers stasis in the rectum)
- •From organic origin
- •Recent (<6 mois)
- •Relieved using osmotic or stimulant laxatives
- •Contra-indication to the use of high resolution manometry insertion
- •Intestinal occlusion
- •Coagulation disorders, including anti-coagulant treatments
- •General anesthesia contra-indication
- •colonoscopy contra-indication
- •failure to perform a colonoscopy in previous attempts
- •medication intake that may impair colorectal motility, including opioids
- •Evolutive inflammatory of neoplasia process
- •History of major digestive surgery (at exclusion of appendicectomy, cholecystectomy)
- •Presence of condition that may impact digestive motility, including diabetes mellitus and sclerodermia
- •Cardiologic disease that may represent a contraindication to vagal stimulation
- •For Healthy volunteers
- •Inclusion Criteria:
- •Age between 18 and 65 years
- •Affiliated to French national healthcare insurance
- •Exclusion Criteria:
- •Significant digestive evolutive disease
- •constipation with Kess score > 11/39 and colonic transit time ≥ 60 h
- •Contra-indication to the use of high resolution manometry insertion
- •Intestinal occlusion
- •Cardiac disease
- •Coagulation disorders, including anti-coagulant treatments
- •General anesthesia contra-indication
- •colonoscopy contra-indication
- •History of major digestive surgery (at exclusion of appendicectomy, cholecystectomy)
- •Presence of condition that may impact digestive motility, including diabetes mellitus and sclerodermia
研究组 & 干预措施
Patients
Patient with constipation will have a high resolution manometry
干预措施: High resolution manometry (Device)
Healthy volunteers
Healthy volunteers will have a high resolution manometry
干预措施: High resolution manometry (Device)
结局指标
主要结局
Frequency of isolated propagated colonic contractions
时间窗: 24 hours
Number of colonic contractions during 24 hours
次要结局
- Speed of isolated propagated colonic contractions(24 hours)
- Colonic transit time(during the first 24 hours)