Usefulness of High Resolution Manometry in Constipation

Обзор

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.

Вмешательства

• Устройство High resolution manometry
  High resolution manometry

Первичные конечные точки

• Frequency of isolated propagated colonic contractions [Срок оценки: 24 hours]

Вторичные конечные точки (2)

• Speed of isolated propagated colonic contractions [Срок оценки: 24 hours]
• Colonic transit time [Срок оценки: during the first 24 hours]

Критерии участия

For patient

Критерии включения

• 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

Критерии исключения

• 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

Критерии включения

• Age between 18 and 65 years
• Affiliated to French national healthcare insurance

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 3 центра

• CHU CAEN — Caen
• Chu Lille — Lille
• Rouen University Hospital — Rouen

Идентификаторы

NCT: NCT04623359 · 2014/047/HP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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