Anorectal MalformationsNCT07029984
Baylor Continence Scale Validity in Anorectal Malformation
An observational study of Anorectal Malformations, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the validity and reliability of the Baylor Continence Scale in Turkish-speaking children diagnosed with anorectal malformations. The scale is used to assess continence levels, helping healthcare providers make informed decisions regarding treatment and follow-up. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Anorectal Malformations
- What is being tested?
- Baylor Continence Scale
- How many people
- 230 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2025to Jun 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Inclusion criteria for the study include children who have undergone surgery due to anorectal malformation, are between 6 and 18 years old. Exclusion criteria consist of cases where the child and caregiver have comprehension, hearing, or vision problems that could affect communication or participation in the study.
Who may be able to join
- Having undergone surgery due to anorectal malformation
- Being between 6 and 18 years old
- The child and caregiver are required to know Turkish
Who cannot join
- The child and caregiver having comprehension, hearing, or vision problems
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ayşe Kayalı Vatansever, Assistant Professor, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University Department of Pediatric Surgery and Bakırçay University Physical Therapy and Rehabilitation Application and Research Center
Izmir
About this study
Official title: Baylor Continence Scale in Children With Anorectal Malformations: A Turkish Validity and Reliability Study
The aim of this study is to evaluate the validity and reliability of the Baylor Continence Scale in Turkish-speaking children diagnosed with anorectal malformations. The scale is used to assess continence levels, helping healthcare providers make informed decisions regarding treatment and follow-up. The study includes a sample of children with confirmed anorectal malformations, and data collection consists of language adaptation, statistical validation, and reliability testing. Results will contribute to the standardization of continence assessment in Turkish clinical settings, ensuring accurate evaluations for pediatric patients.
- Conditions
- Anorectal Malformations
- Being tested
- Baylor Continence Scale
- Keywords
- Anorectal Malformation, Baylor Continence Scale, Validity and Reliability
- Medical subject headings
- Anorectal Malformations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baylor Continence ScaleOther
This study may be one of the first to test the Turkish adaptation and validity of the scale in Turkish children with anorectal malformations.
| Study group | Role | What they receive |
|---|---|---|
| Children with Anorectal Malformations | Having undergone surgery due to anorectal malformations, Being between 6 and 18 years of age, The child and caregiver knowing Turkish Receives: Other: Baylor Continence Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validity and Reliability Analyses
In this study, validity and reliability analyses will be conducted as part of the Turkish adaptation of the Baylor Continence Scale.
Measured: Average 6 to 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start10 May 2025
- Primary completionMay 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorectal MalformationsStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University
- Responsible party
- Principal investigator, AYŞE KAYALI VATANSEVER, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029984
- Sponsor's protocol ID
- 2015
- Status last verified
- Feb 2026
- First submitted
- 12 Jun 2025
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Baylor Continence Scale in Children With Anorectal Malformations: A Turkish Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT07029984
- Acronym / sponsor ID
- 2015
- Conditions
- Anorectal Malformations
- Keywords
- Anorectal Malformation, Baylor Continence Scale, Validity and Reliability
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Collaborators
- Ege University
- Study start
- 10 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Jun 2025 (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 validity and reliability of the Baylor Continence Scale in Turkish-speaking children diagnosed with anorectal malformations. The scale is used to assess continence levels, helping healthcare providers make informed decisions regarding treatment and follow-up. The study includes a sample of children with confirmed anorectal malformations, and data collection consists of language adaptation, statistical validation, and reliability testing. Results will contribute to the standardization of continence assessment in Turkish clinical settings, ensuring accurate evaluations for pediatric patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Anorectal Malformations | – | Other: Baylor Continence ScaleHaving undergone surgery due to anorectal malformations, Being between 6 and 18 years of age, The child and caregiver knowing Turkish |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Inclusion criteria for the study include children who have undergone surgery due to anorectal malformation, are between 6 and 18 years old. Exclusion criteria consist of cases where the child and caregiver have comprehension, hearing, or vision problems that could affect communication or participation in the study.
Key inclusion criteria (3 listed)
- Having undergone surgery due to anorectal malformation
- Being between 6 and 18 years old
- The child and caregiver are required to know Turkish
Key exclusion criteria (1 listed)
- The child and caregiver having comprehension, hearing, or vision 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 |
|---|---|---|
| Baylor Continence ScaleThis study may be one of the first to test the Turkish adaptation and validity of the scale in Turkish children with anorectal malformations. | Other | Children with Anorectal Malformations |
Primary outcome
Validity and Reliability Analyses
Time frame: Average 6 to 12 month
In this study, validity and reliability analyses will be conducted as part of the Turkish adaptation of the Baylor Continence Scale.
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 17 Feb 2026.
- Individual participant dataSharing planned: No
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Anorectal Malformations
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.
Ayşe Kayalı Vatansever, Assistant Professor, PhD contact
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 Anorectal Malformations, run by Izmir Bakircay University 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 1 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: looking for participants now, as of the sponsor's last update on 17 Feb 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?
Contact Ayşe Kayalı Vatansever, Assistant Professor, PhD (+905529382360, ayse.vatansever@bakircay.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validity and Reliability Analyses (time frame: Average 6 to 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.