Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Not Applicable

• Conditions: Gastrointestinal Motility Disorder
• Interventions: Diagnostic Test: High resolution intestinal manometry

• Registration Number: NCT04764019
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-07
• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-17
• Study First Posted: 2021-02-21
• Status Verified: 2021-03
• Primary Completion: 2021-07-15
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-22
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients: digestive symptoms
• Healthy subjects: asymptomatic

Exclusion Criteria

• Patients: organic disorders
• Healthy subjects: organic disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	High resolution intestinal manometry	Patients with chronic digestive symptoms in whom intestinal dysmotility is suspected

Primary Outcome Measures

Name	Time	Method
Contractile activity	10 minutes	Number of contractions

Trial Locations

Locations (1)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain