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ClinicalTrials.gov ID

NCT04623359

Lead Sponsor

University Hospital, RouenOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

76Estimated

Last Update Posted

Feb 6, 2026Actual

Start Date

Jan 25, 2023Actual

Primary Completion Date

Sep 2027Estimated

Completion Date

Sep 2027Estimated

Official Title

Usefulness of High Resolution Manometry in Constipation

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.

• Constipation

• High resolution manometry

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

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

Primary Purpose

Diagnostic

Allocation

Non-Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University Hospital, RouenOTHER

Pauline.wils@chru-lille.fr