Usefulness of High Resolution Manometry in Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High resolution manometry.
- Who it may be relevant to
- Registry conditions: Constipation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device High resolution manometry
High resolution manometry
Primary outcome measures
- Frequency of isolated propagated colonic contractions [Time frame: 24 hours]
Secondary outcome measures (2)
- Speed of isolated propagated colonic contractions [Time frame: 24 hours]
- Colonic transit time [Time frame: during the first 24 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 3 centers
- CHU CAEN — Caen
- Chu Lille — Lille
- Rouen University Hospital — Rouen
Identifiers
NCT: NCT04623359 · 2014/047/HP