NCT07029984

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
230

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
May 2025Jun 2026

Study Start

First participant enrolled

May 10, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

12 months

First QC Date

June 12, 2025

Last Update Submit

February 12, 2026

Conditions

Keywords

Anorectal MalformationBaylor Continence ScaleValidity and Reliability

Outcome Measures

Primary Outcomes (1)

  • 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.

    Average 6 to 12 month

Study Arms (1)

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

Other: Baylor Continence Scale

Interventions

This study may be one of the first to test the Turkish adaptation and validity of the scale in Turkish children with anorectal malformations.

Children with Anorectal Malformations

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Having undergone surgery due to anorectal malformation
  • Being between 6 and 18 years old
  • The child and caregiver are required to know Turkish

You may not qualify if:

  • The child and caregiver having comprehension, hearing, or vision problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University Department of Pediatric Surgery and Bakırçay University Physical Therapy and Rehabilitation Application and Research Center

Izmir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anorectal Malformations

Condition Hierarchy (Ancestors)

Digestive System AbnormalitiesDigestive System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Ayşe Kayalı Vatansever, Assistant Professor, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD

Study Record Dates

First Submitted

June 12, 2025

First Posted

June 19, 2025

Study Start

May 10, 2025

Primary Completion

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations