Status:
ENROLLING_BY_INVITATION
Influence of Body Position on the Defecation Model During Anorectal Manometry.
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
Medtronic
Conditions:
Constipation
Children
Eligibility:
All Genders
4-18 years
Brief Summary
Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure p...
Detailed Description
Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry in both- sitted and lying position. During anorectal manometry conv...
Eligibility Criteria
Inclusion
- Inclusion criteria - the study group:
- age from 5 to 18 years old
- functional constipation diagnosed on the basis of Rome IV criteria
- parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent
- Inclusion criteria - the control group:
- age from 5 to 18 years old
- no lower gastrointestinal symptoms
- parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent
- Exclusion criteria - the study group and the control group:
- undergone surgeries due to congenital anomalies in the lower gastrointestinal tract
- inflammatory bowel diseases or inflammation of the large intestine with a different aetiology
- anal fissure, inflammation of the anal area or other conditions which, in the opinion of the researcher, could affect the functioning of the distal gastrointestinal tract
Exclusion
Key Trial Info
Start Date :
January 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06924957
Start Date
January 10 2020
End Date
December 1 2025
Last Update
September 18 2025
Active Locations (1)
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1
The Department of Paediatric Gastroenterology and Nutrition, Warsaw Medical University
Warsaw, Masovian Voivodeship, Poland, 02-091