Clinical trial NCT04623359: Usefulness of High Resolution Manometry in Constipation
Official title: Usefulness of High Resolution Manometry in Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Constipation
Keywords: high resolution manometry
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2020-11-10
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


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 outcomes:
measure: Frequency of isolated propagated colonic contractions
timeFrame: 24 hours
Secondary outcomes:
measure: Speed of isolated propagated colonic contractions
timeFrame: 24 hours
measure: Colonic transit time
timeFrame: during the first 24 hours
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Guillaume GOURCEROL
role: PRINCIPAL_INVESTIGATOR
References: