Usefulness of High Resolution Manometry in Constipation (MANOCOHR)

February 5, 2026 updated by: University Hospital, Rouen
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Caen, France, 14033
        • Recruiting
        • CHU caen
        • Contact:
        • Sub-Investigator:
          • Marie-Astrid Piquet, Pr
      • Lille, France, 59037
      • Rouen, France
        • Recruiting
        • Rouen University Hospital
        • Contact:
        • Principal Investigator:
          • Anne-Marie LEROI, Pr
        • Sub-Investigator:
          • Guillaume Gourcerol, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
Patient with constipation will have a high resolution manometry
Device: High resolution manometry
High resolution manometry
Other: Healthy volunteers
Healthy volunteers will have a high resolution manometry
Device: High resolution manometry
High resolution manometry

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Guillaume GOURCEROL, University Hospital, Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

November 4, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 10, 2020

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/047/HP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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