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Usefulness of High Resolution Manometry in Constipation

Usefulness of High Resolution Manometry in Constipation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04623359
Acronym
MANOCOHR
Enrollment
76
Registered
2020-11-10
Start date
2023-01-25
Completion date
2027-09-01
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation

Keywords

high resolution manometry

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.

Interventions

High resolution manometry

Sponsors

University Hospital, Rouen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Frequency of isolated propagated colonic contractions24 hoursNumber of colonic contractions during 24 hours

Secondary

MeasureTime frameDescription
Speed of isolated propagated colonic contractions24 hoursAverage speed of colonic contractions during 24 hours
Colonic transit timeduring the first 24 hoursTransit time will be measured during during the first 24 hours

Countries

France

Contacts

CONTACTGuillaume GOURCEROL, Pr
guillaume.gourcerol@chu-rouen.fr02 32 88
CONTACTJulien BLOT
julien.blot@chu-rouen.fr+3323288
PRINCIPAL_INVESTIGATORGuillaume GOURCEROL

University Hospital, Rouen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026