Rectum DiameterNCT07656896
Measurement of Ultrasonographic Rectal Diameter in Children With Constipation
An observational study of Rectum Diameter and Constipation, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the diagnostic accuracy of rectal diameter measured by ultrasonography in predicting constipation defined by clinical criteria. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Rectum Diameter, Constipation, Rome IV Functional Constipation
- What is being tested?
- Ultrasonographic rectal diameter measurement
- Type of treatment
- Injection or infusion
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2024to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Undergoing transabdominal ultrasonographic evaluation of rectal diameter
- Evaluated according to the Rome IV criteria
- Between 5-17 years old
Who cannot join
- Neurological conditions
- Constipation associated with anatomical problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sancaktepe Sehit Prof dr Ilhan Varank Training and Research Hospital
Istanbul
About this study
Official title: 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.
- Being tested
- Ultrasonographic rectal diameter measurement
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic rectal diameter measurementDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Constipation cohort | Children diagnosed with constipation according to Rome IV criteria who underwent transabdominal ultrasonographic measurement of rectal diameter. Receives: Diagnostic Test: Ultrasonographic rectal diameter measurement | |
| Control cohort | Children without symptoms of constipation who underwent transabdominal ultrasonographic measurement of rectal diameter. Receives: Diagnostic Test: Ultrasonographic rectal diameter measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Receiver Operating Characteristic Curve for Ultrasonographic Rectal Diameter in Diagnosing Functional Constipationent
Area under the receiver operating characteristic curve (AUC) of transabdominal ultrasonographic rectal diameter measurement for discriminating children with constipation from non-constipated children.
Measured: Baseline
Secondary outcomes (1)
Optimal Rectal Diameter Cut-off Value for Diagnosing Functional Constipation
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start1 Aug 2024
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectum DiameterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Furkan Adem Canbaz, Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656896
- Sponsor's protocol ID
- US rectal diameter
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30176757Dogan 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.
PubMed 36510402
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Ultrasonographic Rectal Diameter for Identifying Constipation in Children
- ClinicalTrials.gov ID
- NCT07656896
- Acronym / sponsor ID
- US rectal diameter
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constipation cohort | – | Diagnostic Test: Ultrasonographic rectal diameter measurementChildren diagnosed with constipation according to Rome IV criteria who underwent transabdominal ultrasonographic measurement of rectal diameter. |
| Control cohort | – | Diagnostic Test: Ultrasonographic rectal diameter measurementChildren without symptoms of constipation who underwent transabdominal ultrasonographic measurement of rectal diameter. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Undergoing transabdominal ultrasonographic evaluation of rectal diameter
- Evaluated according to the Rome IV criteria
- Between 5-17 years old
Key exclusion criteria (2 listed)
- Neurological conditions
- Constipation associated with anatomical problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonographic rectal diameter measurementTransabdominal 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. | Diagnostic test | Constipation cohort, Control cohort |
Primary outcome
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.
1 secondary outcome
Optimal Rectal Diameter Cut-off Value for Diagnosing Functional Constipation
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Background: PubMed 30176757Jansson 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.
- Background: PubMed 36510402Dogan 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectum Diameter and Constipation, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Receiver Operating Characteristic Curve for Ultrasonographic Rectal Diameter in Diagnosing Functional Constipationent (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07656896, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.