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NOT YET RECRUITING
NCT07291661
NA

The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation

Sponsor: Assiut University

View on ClinicalTrials.gov

Summary

This research protocol outlines a two-year descriptive cross-sectional study to investigate the role of high-resolution anorectal manometry (HRAM) in children aged 4-18 years with chronic refractory constipation.The study plans to enroll 54 patients at Ain Shams University Specialized Hospital . The study aims to identify different patterns of anorectal dysfunction (like dyssynergic defecation or rectal hyposensitivity) using standardized international protocols. A key goal is to determine if these manometry findings can directly guide specific management strategies, such as biofeedback therapy for dyssynergia or botulinum toxin injections for anal hypertension. improving outcomes for children who do not respond to standard constipation therapies.

Official title: The Role of Anorectal Manometry in Diagnosing and Guiding Management of Pediatric Chronic Refractory Constipation

Key Details

Gender

All

Age Range

4 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2026-01-01

Completion Date

2027-12-31

Last Updated

2025-12-18

Healthy Volunteers

No

Interventions

DEVICE

High resolution anorectal manometry using a multiuse water perfused catheter

According to the international anorectal physiology working group recommendations(8): Stabilization: A 3-minute period after catheter insertion to allow anal tone to return to baseline. * Rest: Measures basal anal tone over 60 seconds. * Squeeze: Records anal pressure during voluntary contraction. Three 5-second squeezes are performed. * Long Squeeze: Evaluates anal pressure and fatigue during a single sustained 30-second contraction. * Cough: Assesses reflex anal pressure changes during two single coughs. * Push: Measures pressure changes during simulated defecation. Three 15-second pushes are performed. * RAIR (Rectoanal Inhibitory Reflex): Tests reflex anal relaxation after rapid rectal balloon distension, starting with at least 30 mL. Rectal Sensory Test: Measures rectal sensitivity by recording balloon volumes at three thresholds: first constant sensation, desire to defecate, and maximum tolerated volumes. · Balloon Expulsion: time required to expel the balloon.

Locations (1)

Assiut University-faculty of medicine

Asyut, Egypt