ROLE OF PELVIC ULTRASOUND IN THE TREATMENT MONITORING OF CHILDREN WITH CHRONIC Idiopathic Constip… (NCT05787093) | Clinical Trial Compass
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ROLE OF PELVIC ULTRASOUND IN THE TREATMENT MONITORING OF CHILDREN WITH CHRONIC Idiopathic Constipation
Italy123 participantsStarted 2022-09-01
Plain-language summary
Constipation is a frequently encountered problem in childhood, with a prevalence ranging between 1 and 30%. Several studies have proposed pelvic ultrasound, (simple, non-invasive and reproducible) both to define the presence of megarectum, and to follow the answer to treatment, but the real utility remains to be defined, especially in the follow-up.The primary aim of the study is to evaluate whether, in the conventional treatment of functional constipation of the child, the variations of the rectal diameter, measured through the use of the pelvic ultrasound, are a good marker of disease severity and efficacy of the treatment.
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:
* pediatric patients (between 4 and 18 years of age) accessing the services outpatient or pediatric first aid for constipation (according to Rome IV criteria)
* rectal diameter superior to 3 cm on the transabdominal echo
* presence of informed consent to participation in the study by minors and children parents/legal guardians
Exclusion Criteria:
* age under 4 years;
* previous anorectal surgery;
* suspicion of anamnestic and/or clinical examination of an organic cause of constipation.rectal diameter \< 3 cm on the transabdominal echo
* absence of informed consent to participation in the study by minors and parents/guardians legal.
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.