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Usefulness of High Resolution Manometry in Constipation

NCT ID: NCT04623359

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-31

Study Completion Date

2024-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Constipation

Keywords

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high resolution manometry

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients

Patient with constipation will have a high resolution manometry

Group Type EXPERIMENTAL

High resolution manometry

Intervention Type DEVICE

High resolution manometry

Healthy volunteers

Healthy volunteers will have a high resolution manometry

Group Type OTHER

High resolution manometry

Intervention Type DEVICE

High resolution manometry

Interventions

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High resolution manometry

High resolution manometry

Intervention Type DEVICE

Eligibility Criteria

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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


* Age between 18 and 65 years
* 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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume GOURCEROL

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

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Rouen University Hospital

Rouen, , France

Site Status

Countries

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France

Central Contacts

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Guillaume GOURCEROL, Pr

Role: CONTACT

Phone: 02 32 88

Email: [email protected]

Julien BLOT

Role: CONTACT

Phone: +3323288

Email: [email protected]

Facility Contacts

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Guillaume GOURCEROL, Pr

Role: primary

Other Identifiers

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2014/047/HP

Identifier Type: -

Identifier Source: org_study_id