Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Vall d'Hebron University Hospital (HUVH)

Status: Unknown

Conditions: Gastrointestinal Motility Disorder

Treatments: Diagnostic Test: High resolution intestinal manometry

Study type: Interventional

Funder types: Other

Identifiers

NCT04764019

PR(AG)56/2018

Details and patient eligibility

About

Automatic and non-invasive diagnostic methods based on the analysis of internal (intraluminal) and external (abdominal) images have been recently developed to measure intestinal motility. In patients with severe motor disorders, such as intestinal pseudo-obstruction, these new non-invasive techniques have shown to be equivalent to conventional intestinal manometry, the current gold-standard. However, these new techniques also detect less obvious signs of intestinal motor dysfunction, which are not detectable by conventional manometry.

High resolution manometry has been recently been applied to other parts of the digestive tract with great success, and probably will replace the actual gold-standard for intestinal motility evaluation. The investigators expect high-resolution manometry to be more sensitive than conventional manometry to the subtle motility disturbances detected by the new non-invasive techniques.

The purpose of this project is to demonstrate that intestinal motor function can be measured more sensitively and accurately using a combination of new technologies: high resolution manometry and the non-invasive diagnostic methods based on the analysis of images. The combined use of these techniques, following a step-wise algorithm, could allow to determine the mechanism, the affected regions and severity of the dysfunction in patients with intestinal dysmotility.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients: digestive symptoms
• Healthy subjects: asymptomatic

Exclusion criteria

• Patients: organic disorders
• Healthy subjects: organic disorders

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Patients

Experimental group

Description:

Patients with chronic digestive symptoms in whom intestinal dysmotility is suspected

Treatment:

Diagnostic Test: High resolution intestinal manometry