Influence of Body Position on the Defecation Model During Anorectal Manometry. (NCT06924957) | Clinical Trial Compass
By InvitationNot Applicable
Influence of Body Position on the Defecation Model During Anorectal Manometry.
Poland120 participantsStarted 2020-01-10
Plain-language 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 profile of anorectum and may indicate impaired defecation dynamics. Resent studies suggest that the position in which 3D HRAM is performed should be changed. So far, no scientific research has been performed in children that directly compares both positions. The reference values of registered pressures during 3D HRAM in people without complaints were not specified, which would allow for a more precise diagnosis of patients with an incorrect defecation model and precise selection of patients who could benefit from biofeedback therapy.
Who can participate
Age range
4 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.