High-resolution manometry for chronic constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study uses a high-resolution manometric probe to map colorectal contractile activity in adults with chronic constipation and in healthy volunteers. Participants will undergo catheter insertion and recordings of colorectal motor patterns, and the resulting measures will be compared between patients and controls and against existing diagnostic criteria. Enrollment focuses on adults aged 18–65 with constipation >6 months, delayed colonic transit (>100 h), a normal colonoscopy, and prior failure of at least one osmotic and one stimulant laxative. The main goal is to determine whether high-resolution manometry provides diagnostic parameters that more reliably identify colonic inertia than conventional methods.

Why it matters

Who can join: the full rules

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

Where it's running

• Chu Caen
  Caen, France Recruiting
• Chu Lille
  Lille, France Recruiting
• Rouen University Hospital
  Rouen, France Recruiting

Study contacts

• Principal investigator: Guillaume GOURCEROL — University Hospital, Rouen
• Study coordinator: Guillaume GOURCEROL, Pr
• Email: guillaume.gourcerol@chu-rouen.fr
• Phone: 02 32 88

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.