Usefulness of High Resolution Manometry in Constipation

Constipation Clinical Trial

— MANOCOHR  

Official title:

Usefulness of High Resolution Manometry in Constipation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04623359
• Other study ID #: 2014/047/HP
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: September 2024

Study information

• Verified date: November 2020
• Source: University Hospital, Rouen
• Contact: Guillaume GOURCEROL, Pr
• Phone: 02 32 88
• Email: guillaume.gourcerol[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation

Intervention

Device:
• High resolution manometry
High resolution manometry

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of isolated propagated colonic contractions	Number of colonic contractions during 24 hours	24 hours
Secondary	Speed of isolated propagated colonic contractions	Average speed of colonic contractions during 24 hours	24 hours
Secondary	Colonic transit time	Transit time will be measured during during the first 24 hours	during the first 24 hours