NCT04623359

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Jan 2023Sep 2027

First Submitted

Initial submission to the registry

November 4, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 10, 2020

Completed
2.2 years until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

4.6 years

First QC Date

November 4, 2020

Last Update Submit

February 5, 2026

Conditions

Constipation

Keywords

high resolution manometry

Outcome Measures

Primary Outcomes (1)

  • Frequency of isolated propagated colonic contractions

    Number of colonic contractions during 24 hours

    24 hours

Secondary Outcomes (2)

  • Speed of isolated propagated colonic contractions

    24 hours

  • Colonic transit time

    during the first 24 hours

Study Arms (2)

Patients

EXPERIMENTAL

Patient with constipation will have a high resolution manometry

Device: High resolution manometry

Healthy volunteers

OTHER

Healthy volunteers will have a high resolution manometry

Device: High resolution manometry

Interventions

High resolution manometryDEVICE

High resolution manometry

Healthy volunteersPatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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
  • Presence of condition that may impact digestive motility, including diabetes mellitus and sclerodermia
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

CHU CAEN

Caen, 14033, France

RECRUITING

Chu Lille

Lille, 59037, France

RECRUITING

Rouen University Hospital

Rouen, France

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Guillaume GOURCEROL

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guillaume GOURCEROL, Pr

CONTACT

02 32 88guillaume.gourcerol@chu-rouen.fr

Julien BLOT

CONTACT

+3323288julien.blot@chu-rouen.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2020

First Posted

November 10, 2020

Study Start

January 25, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)