- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07656896
Measurement of Ultrasonographic Rectal Diameter in Children With Constipation
June 16, 2026 updated by: Furkan Adem Canbaz, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Diagnostic Value of Ultrasonographic Rectal Diameter for Identifying Constipation in Children
The aim of this study is to evaluate the diagnostic accuracy of rectal diameter measured by ultrasonography in predicting constipation defined by clinical criteria.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey (Türkiye)
- Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the Pediatric Urology Clinic of Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital who underwent evaluation for constipation using ultrasonographic rectal diameter measurement in conjunction with Rome IV criteria.
Description
Inclusion Criteria:
- Undergoing transabdominal ultrasonographic evaluation of rectal diameter
- Evaluated according to the Rome IV criteria
- Between 5-17 years old
Exclusion Criteria:
- Neurological conditions
- Constipation associated with anatomical problems
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Constipation cohort
Children diagnosed with constipation according to Rome IV criteria who underwent transabdominal ultrasonographic measurement of rectal diameter.
|
Transabdominal ultrasonographic measurement of rectal diameter was performed to evaluate fecal retention and diagnose constipation in children.
Rectal diameter measurements were compared with clinical diagnostic criteria.
|
|
Control cohort
Children without symptoms of constipation who underwent transabdominal ultrasonographic measurement of rectal diameter.
|
Transabdominal ultrasonographic measurement of rectal diameter was performed to evaluate fecal retention and diagnose constipation in children.
Rectal diameter measurements were compared with clinical diagnostic criteria.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Area Under the Receiver Operating Characteristic Curve for Ultrasonographic Rectal Diameter in Diagnosing Functional Constipationent
Time Frame: Baseline
|
Area under the receiver operating characteristic curve (AUC) of transabdominal ultrasonographic rectal diameter measurement for discriminating children with constipation from non-constipated children.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Optimal Rectal Diameter Cut-off Value for Diagnosing Functional Constipation
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Jansson E, Neveus T. Rectal diameter assessment in enuretic children-exploring the association between constipation and bladder function. Ups J Med Sci. 2018 Sep;123(3):179-182. doi: 10.1080/03009734.2018.1488778. Epub 2018 Sep 4.
- Dogan G, Keceli M, Yavuz S, Topcu A, Kasirga E. Measurement of Rectal Diameter and Anterior Wall Thickness by Ultrasonography in Children with Chronic Constipation. Turk J Gastroenterol. 2022 Dec;33(12):1062-1068. doi: 10.5152/tjg.2022.22165.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2024
Primary Completion (Estimated)
August 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
June 16, 2026
First Submitted That Met QC Criteria
June 16, 2026
First Posted (Actual)
June 18, 2026
Study Record Updates
Last Update Posted (Actual)
June 18, 2026
Last Update Submitted That Met QC Criteria
June 16, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- US rectal diameter
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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