High-resolution manometry for chronic constipation

Usefulness of High Resolution Manometry in Constipation

This study will test whether high-resolution manometry can better detect abnormal colorectal muscle activity in adults (18–65) with chronic constipation that has not improved with laxatives.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Rouen (other)
• Locations: 3 sites (Caen and 2 other locations)
• Trial ID: NCT04623359 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 with chronic constipation for over six months, documented delayed colonic transit (>100 h), normal colonoscopy, refractory to both an osmotic and a stimulant laxative, and affiliated with French national health insurance.

Not a fit: Patients with distal (rectal) constipation, colonic transit <100 h, organic causes of constipation, recent onset symptoms, current use of opioids or other drugs that impair colorectal motility, or contraindications to manometry are unlikely to benefit from this test.

Why it matters

Potential benefit: If successful, this approach could more accurately identify patients with colonic inertia so they can receive appropriate medical or surgical treatment instead of prolonged ineffective therapies.

How similar studies have performed: Conventional manometry has detected severe colorectal motility abnormalities in only a small subset of patients, and while high-resolution manometry gives more detailed maps of activity, its clinical value has not yet been proven in prior studies.

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

Where this trial is running

Caen and 2 other locations

• 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

Conditions: Constipation, high resolution manometry