Usefulness of High Resolution Manometry in Constipation

Study Overview
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Brief Summary
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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.

Official Title
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Usefulness of High Resolution Manometry in Constipation

Conditions
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Constipation

Intervention / Treatment
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* Device: High resolution manometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Patient with constipation will have a high resolution manometry | Device: High resolution manometry<br>* High resolution manometry<br>|
| Other: Healthy volunteers<br>Healthy volunteers will have a high resolution manometry | Device: High resolution manometry<br>* High resolution manometry<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of isolated propagated colonic contractions | Number of colonic contractions during 24 hours | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of isolated propagated colonic contractions | Average speed of colonic contractions during 24 hours | 24 hours | 
| Colonic transit time | Transit time will be measured during during the first 24 hours | during the first 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high resolution manometry