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Usefulness of High Resolution Manometry in Constipation

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Rouen
NCT04623359 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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 Exclusion Criteria: * 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
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What it tests

  • High resolution manometry
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Where

3 sites
CHU CAEN
Caen, France
Chu Lille
Lille, France
Rouen University Hospital
Rouen, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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