Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT04623359

Usefulness of High Resolution Manometry in Constipation

Led by University Hospital, Rouen · Updated on 2026-02-06

76

Participants Needed

3

Research Sites

240 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Usefulness of High Resolution Manometry in Constipation

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Chronic constipation lasting more than 6 months
  • Delayed colonic transit time greater than 100 hours
  • Normal colonoscopy
  • Constipation not improved by at least one osmotic and one stimulant laxative according to French guidelines
  • Affiliated to French national healthcare insurance
Not Eligible

You will not qualify if you...

  • Colonic transit time less than 100 hours
  • Distal constipation with stasis in the rectum
  • Constipation of organic origin
  • Recent constipation less than 6 months
  • Constipation relieved by osmotic or stimulant laxatives
  • Contraindications to high resolution manometry such as intestinal occlusion, coagulation disorders, contraindications to general anesthesia or colonoscopy
  • Failure to perform colonoscopy previously
  • Medication affecting colorectal motility including opioids
  • Progressive inflammatory or neoplastic diseases
  • History of major digestive surgery (except appendectomy or cholecystectomy)
  • Conditions affecting digestive motility such as diabetes mellitus and scleroderma
  • Cardiac diseases contraindicating vagal stimulation
  • Significant digestive diseases for healthy volunteers
  • Constipation with Kess score greater than 11/39 and colonic transit time 60 hours or more for healthy volunteers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

CHU CAEN

Caen, France, 14033

Actively Recruiting

2

Chu Lille

Lille, France, 59037

Actively Recruiting

3

Rouen University Hospital

Rouen, France

Actively Recruiting

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Research Team

G

Guillaume GOURCEROL, Pr

CONTACT

J

Julien BLOT

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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