Usefulness of High Resolution Manometry in Constipation

Recruiting now · Not applicable

Conditions studied: Constipation

In brief

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.

Key facts

Study ID

NCT04623359

Run by

University Hospital, Rouen

People needed

76

Starts

2023-01-25

Expected to finish

2027-09-01

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU CAEN — Caen, France (enrolling)
• Chu Lille — Lille, France (enrolling)
• Rouen University Hospital — Rouen, France (enrolling)

Full record on ClinicalTrials.gov

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