Measurement of Ultrasonographic Rectal Diameter in Children With Constipation

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

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

      • Istanbul, Turkey (Türkiye)
        • Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital

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.

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

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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