ConstipationMANOCOHRNCT04623359
Usefulness of High Resolution Manometry in Constipation
A study testing High resolution manometry in people with Constipation, run by University Hospital, Rouen at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- High resolution manometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 3 sitesFrance
- Study dates
- 25 Jan 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Age between 18 and 65 years
- Affiliated to French national healthcare insurance
Who cannot join
- 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
Show all 28Show fewer
- 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
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
CHU CAEN
Caen, 14033
Marie-Astrid Piquet, Pr, piquet-ma@chu-caen.fr
Marie-Astrid Piquet, Pr
- Recruiting
Chu Lille
Lille, 59037
Pauline Wils, Dr, Pauline.wils@chru-lille.fr
Pauline Wils, Dr
- Recruiting
Rouen University Hospital
Rouen
Guillaume GOURCEROL, Pr, 02 32 88 ext. 8265, guillaume.gourcerol@chu-rouen.fr
Anne-Marie LEROI, Pr
About this study
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
- Constipation
- Being tested
- High resolution manometry
- Keywords
- high resolution manometry
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High resolution manometryDevice
High resolution manometry
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Patient with constipation will have a high resolution manometry Receives: Device: High resolution manometry |
| Healthy volunteers | Other | Healthy volunteers will have a high resolution manometry Receives: Device: High resolution manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of isolated propagated colonic contractions
Number of colonic contractions during 24 hours
Measured: 24 hours
Secondary outcomes (2)
Speed of isolated propagated colonic contractions
Average speed of colonic contractions during 24 hours
Measured: 24 hours
Colonic transit time
Transit time will be measured during during the first 24 hours
Measured: during the first 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study start25 Jan 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume GOURCEROL, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04623359
- Sponsor's protocol ID
- 2014/047/HP
- Acronym
- MANOCOHR
- Status last verified
- Feb 2026
- First submitted
- 4 Nov 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of High Resolution Manometry in Constipation
- ClinicalTrials.gov ID
- NCT04623359
- Acronym / sponsor ID
- MANOCOHR / 2014/047/HP
- Conditions
- Constipation
- Keywords
- high resolution manometry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: High resolution manometryPatient with constipation will have a high resolution manometry |
| Healthy volunteers | Other | Device: High resolution manometryHealthy volunteers will have a high resolution manometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 ;
Key exclusion criteria (28 listed)
- Patient with constipation being either:
- Contra-indication to the use of high resolution manometry insertion
- failure to perform a colonoscopy in previous attempts
- medication intake that may impair colorectal motility, including opioids
- Evolutive inflammatory of neoplasia process
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High resolution manometryHigh resolution manometry | Device | Healthy volunteers, Patients |
Primary outcome
Frequency of isolated propagated colonic contractions
Time frame: 24 hours
Number of colonic contractions during 24 hours
2 secondary outcomes
Speed of isolated propagated colonic contractions
Time frame: 24 hours
Colonic transit time
Time frame: during the first 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillaume GOURCEROL principal investigator
University Hospital, Rouen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High resolution manometry in people with Constipation, run by University Hospital, Rouen at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume GOURCEROL, Pr (02 32 88 ext. 8265, guillaume.gourcerol@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of isolated propagated colonic contractions (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.