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Electrode Placement and Continence Outcomes after Hirschsprung’s Surgery

Impact of Electrode Placement on Continence Outcomes in Pediatric Hirschsprung’s Disease: A Controlled Trial of Rectal Versus Surface Stimulation Approaches after trans- Anal Pull-Through Surgeries

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202510484282271
Enrollment
70
Registered
2025-10-30
Start date
2025-01-10
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Diseases

Interventions

Rectal Electrodes
Surface Electrode

Sponsors

Hany Elgohary
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - aged 6-14 years - reported persistent fecal incontinence after transanal pull-through surgery to correct Hirschsprung disease - were in a stable medical condition - had given their assent as well as the consent of a pediatric surgeon and a pediatrician to participate in the rehabilitation program.

Exclusion criteria

Exclusion criteria: - any neurological disorder that affects continence - other congenital anomalies that may affect bowel functioning - severe intellectual disability that could preclude participation - current gastrointestinal infection or perianal dermatologic condition

Design outcomes

Primary

MeasureTime frame
The Bowel Function Score (BFS) is a properly validated tool that is used to measure bowel functioning and fecal continence in pediatric and clinical cohorts. Its content validity, convergence with similar measures of continence, and sensitivity to clinically significant changes across time periods have been testified to by empirical evidence. Besides, the BFS has a high level of reliability, which is proven by the similarity of the results at consecutive measurements and at different raters when the set of instructions is followed. The scale assesses such areas as the frequency of soiling, stool, the effect of quotidian activity and quality of life, and management feasibility. The scores are then summed to produce a composite index where higher scores represent higher functioning, though score delineations vary based on version. The BFS can be used to inform clinical decision-making, monitor therapeutic trajectories, and provide a standardized measure to be used in research.

Secondary

MeasureTime frame
Pediatric Incontinence and Constipation Scoring System (PICSS), and its strength as a diagnostic and follow-up tool in pediatric bowel and bladder dysfunction (Jiang et al., 2018). The PICSS is an all-inclusive scale of fecal incontinence and constipation severity in children, which proves to be highly reliable in the measurements of urinary incontinence and bowel functions (Verkuijl et al., 2022). Its construct validity is also supported by the fact that it correlates with standard measures of continence and constipation, and it is able to identify clinically significant changes in a time period The tool is especially useful considering the high incidence of bowel and bladder dysfunction in the pediatric urology clinic, where the previously mentioned rates have been reported to reach as high as 47%. Although the use of assessment tools in pediatric urology is increasing, the psychometric testing and validation processes of the questionnaires are highly diverse, which highlights the necessity to agree on gold-standard measures (Filho et al., 2020). Furthermore, even though a number of instruments demonstrate outstanding discriminative features, not many of them have critically assessed responsiveness or incorporated patient-reported bother ratings, which are needed to achieve a comprehensive view of symptom impact. ;PedsQL is a standardized measure that can be employed to assess health-related quality of life in children and adolescents in the most fundamental domains, such as physical, emotional, social, and school functioning. The Arabic PedsQL version has been culturally adapted and demonstrated to be reliable, constructively valid, and responsive to clinical change, making it an appropriate and reliable tool to use in Arabic-speaking pediatric patients.

Countries

Egypt

Contacts

Public ContactFathia ahmed

Department of Physical Therapy for Surgery Faculty of Physical Therapy Cairo University

hmmkno@gmail.com00201094137775

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026