Usefulness of High Resolution Manometry in Constipation (MANOCOHR)

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 Overview

• Status: Not yet recruiting
• Conditions: Constipation
• Intervention / Treatment: Device: High resolution manometry

• Study Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guillaume GOURCEROL, Pr; Phone Number: 8265 02 32 88; Email: guillaume.gourcerol@chu-rouen.fr

Study Locations

• France
  • Rouen, France
    • ROUEN university hospital
    • Sub-Investigator: Anne-Marie LEROI, Pr
    • Contact: Guillaume GOURCEROL, Pr; Phone Number: 8265 02 32 88; Email: guillaume.gourcerol@chu-rouen.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients; Patient with constipation will have a high resolution manometry	Device: High resolution manometry; High resolution manometry
Other: Healthy volunteers; Healthy volunteers will have a high resolution manometry	Device: High resolution manometry; High resolution manometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of isolated propagated colonic contractions	Number of colonic contractions during 24 hours	24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Rouen
• Investigators: Principal Investigator: Guillaume GOURCEROL, ROUEN university hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2021
• Primary Completion (Anticipated): September 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: November 4, 2020
• First Submitted That Met QC Criteria: November 4, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 4, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: high resolution manometry
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: 2014/047/HP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No