RecruitingNot ApplicableNCT04623359

Usefulness of High Resolution Manometry in Constipation


Sponsor

University Hospital, Rouen

Enrollment

76 participants

Start Date

Jan 25, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • For patient
  • 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 Criteria28

  • 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

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Interventions

DEVICEHigh resolution manometry

High resolution manometry


Locations(3)

CHU CAEN

Caen, France

Chu Lille

Lille, France

Rouen University Hospital

Rouen, France

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NCT04623359


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