NCT04623359 Usefulness of High Resolution Manometry in Constipation
| NCT ID | NCT04623359 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Rouen |
| Condition | Constipation |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2023-01-25 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 76 participants in total. It began in 2023-01-25 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Guillaume GOURCEROL
PRINCIPAL INVESTIGATOR
University Hospital, Rouen
Frequently Asked Questions
Who can join the NCT04623359 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Constipation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04623359 currently recruiting?
Yes, NCT04623359 is actively recruiting participants. Contact the research team at guillaume.gourcerol@chu-rouen.fr for enrollment information.
Where is the NCT04623359 trial being conducted?
This trial is being conducted at Caen, France, Lille, France, Rouen, France.
Who is sponsoring the NCT04623359 clinical trial?
NCT04623359 is sponsored by University Hospital, Rouen. The principal investigator is Guillaume GOURCEROL at University Hospital, Rouen. The trial plans to enroll 76 participants.