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Usefulness of High Resolution Manometry in Constipation (MANOCOHR)

Primary Purpose

Constipation

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
High resolution manometry
Sponsored by
University Hospital, Rouen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Constipation focused on measuring high resolution manometry

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Rouen University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patients

Healthy volunteers

Arm Description

Patient with constipation will have a high resolution manometry

Healthy volunteers will have a high resolution manometry

Outcomes

Primary Outcome Measures

Frequency of isolated propagated colonic contractions
Number of colonic contractions during 24 hours

Secondary Outcome Measures

Speed of isolated propagated colonic contractions
Average speed of colonic contractions during 24 hours
Colonic transit time
Transit time will be measured during during the first 24 hours

Full Information

First Posted
November 4, 2020
Last Updated
November 4, 2020
Sponsor
University Hospital, Rouen
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1. Study Identification

Unique Protocol Identification Number
NCT04623359
Brief Title
Usefulness of High Resolution Manometry in Constipation
Acronym
MANOCOHR
Official Title
Usefulness of High Resolution Manometry in Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
high resolution manometry

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Arm Description
Patient with constipation will have a high resolution manometry
Arm Title
Healthy volunteers
Arm Type
Other
Arm Description
Healthy volunteers will have a high resolution manometry
Intervention Type
Device
Intervention Name(s)
High resolution manometry
Intervention Description
High resolution manometry
Primary Outcome Measure Information:
Title
Frequency of isolated propagated colonic contractions
Description
Number of colonic contractions during 24 hours
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Speed of isolated propagated colonic contractions
Description
Average speed of colonic contractions during 24 hours
Time Frame
24 hours
Title
Colonic transit time
Description
Transit time will be measured during during the first 24 hours
Time Frame
during the first 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume GOURCEROL, Pr
Phone
02 32 88
Ext
8265
Email
guillaume.gourcerol@chu-rouen.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Julien BLOT
Phone
+3323288
Ext
8265
Email
julien.blot@chu-rouen.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume GOURCEROL
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume GOURCEROL, Pr
Phone
02 32 88
Ext
8265
Email
guillaume.gourcerol@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Anne-Marie LEROI, Pr

12. IPD Sharing Statement

Plan to Share IPD
No

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Usefulness of High Resolution Manometry in Constipation

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