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NCT Number: NCT04623359

Usefulness of High Resolution Manometry in Constipation

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.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU CAEN, Caen, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High resolution manometry

Device

High resolution manometry

Primary outcomes

  1. Frequency of isolated propagated colonic contractions

    Time frame: 24 hours

    Number of colonic contractions during 24 hours

Secondary outcomes

  1. Speed of isolated propagated colonic contractions

    Time frame: 24 hours

    Average speed of colonic contractions during 24 hours

  2. Colonic transit time

    Time frame: during the first 24 hours

    Transit time will be measured during during the first 24 hours

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume GOURCEROL, Pr

CONTACT

[email protected]

02 32 88 ext. 8265

Julien BLOT

CONTACT

[email protected]

+3323288 ext. 8265

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: MANOCOHR

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 10, 2020
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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