ClinicalTrials.gg
RecruitingNCT04623359MANOCOHRUpdated Feb 6, 2026

Usefulness of High Resolution Manometry in Constipation

An interventional study of High resolution manometry in Constipation, sponsored by University Hospital, Rouen. Recruiting at 3 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jan 2023; still recruiting 3 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 42 studies in Constipation with a site in France — 5 open to participants now, 5 under way, none of them phase 3. Constipation · France.

Planned enrollment
23rd of 34
76 · median 198
Started
2023
the only one that year
No phase
18 of 42
2 open now
Registered
35th of 42
by date
Lead sponsor
5 of 42
University Hospital, Rouen

Among the 42 studies in Constipation with a site in France, this one is the 23rd largest by planned enrollment of the 34 interventional ones, is the only one that started in 2023, is one of 18 with no phase, and was the 35th registered.

By phase

42 studies; the count open now beside each. This study's row is marked.

No phasethis study18 · 2 open
Observational8 · 3 open
Phase 38 · 0 open
Phase 24 · 0 open
Phase 43 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 1999; this study’s year is marked. 1 started in 2023.

Size and results

Median enrollment 198 across the 34 interventional studies, 90 across the 8 observational. Of the 36 that completed or were terminated, 5 (14%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 42 studies in Constipation with a site in France, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Constipation

Browse trials for

Keywords

  • high resolution manometry
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

For patient

Inclusion Criteria:

  • Age between 18 and 65 years
  • chronic Constipation (> 6 months)
  • delayed colonic transit time > 100 h
  • normal colonoscopy
  • constipation 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
  • 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
76 participants (estimated)

Study arms

  • Experimental
    Patients

    Patient with constipation will have a high resolution manometry

    Device: High resolution manometry

  • Other
    Healthy volunteers

    Healthy volunteers will have a high resolution manometry

    Device: High resolution manometry

Interventions

  • DeviceHigh resolution manometry

    High resolution manometry

06

What researchers measure

Primary outcomes

  1. Frequency of isolated propagated colonic contractions

    Number of colonic contractions during 24 hours

    Time frame: 24 hours

Secondary outcomes

  1. Speed of isolated propagated colonic contractions

    Average speed of colonic contractions during 24 hours

    Time frame: 24 hours

  2. Colonic transit time

    Transit time will be measured during during the first 24 hours

    Time frame: during the first 24 hours

07

Study locations

3 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Sep 2027, 56 months after the start.

Of 243 non-industry interventional studies with no phase under Constipation, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 35. This study's planned 56 months is above that.

Counting every sponsor, half of 314 studies reached it within 14 months; a quarter within 6 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 4, 2020
First posted
Nov 10, 2020
StartActual
Jan 25, 2023
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Feb 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04623359
Responsible party
Sponsor
First posted
Nov 10, 2020
Start date
Jan 25, 2023
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Feb 6, 2026

Study contacts

Guillaume GOURCEROL, Pr
Contact
guillaume.gourcerol@chu-rouen.fr
02 32 88 ext. 8265
Julien BLOT
Contact
julien.blot@chu-rouen.fr
+3323288 ext. 8265
Guillaume GOURCEROL
principal investigator · University Hospital, Rouen

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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