NCT06543979

Anorectal Manometery in Pediatric Chronic Refractory Constipation

The Diagnostic Value of Anorectal Manometry in Pediatric Chronic Refractory Constipation With or Without Fecal Incontinence

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 4 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

Anorectal manometry and high-resolution anorectal manometry (HRAM) are becoming the investigation of choice for understanding the pathophysiology of chronic constipation with or without fecal incontenance in children in many institutions. In high resolution anorectal manometery we are able to gain information whether the symptoms are related to sphincter dysfunction, impaired sensation, or pelvic floor dyssynergia

Detailed description

Primary objective: To assess different patterns of anorectal manometry in children with chronic refractory constipation with or without fecal incontinence. Secondary objective: To determine the effectiveness of different modalities of treatment of chronic refractory constipation based on the anorectal findings. To assess the safety ,tolerability and effectiveness of lubiprostone in pediatric age group with chronic refractory constipation. To assess the effect of elimination of cow milk products in patient with chronic refractory constipation.

Conditions

• Chronic Constipation

Interventions

Type	Name	Description
DRUG	lubiprostone , single arm	laxative
PROCEDURE	biofeed back sessions	Biofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations
PROCEDURE	botox injection	Botulinum toxin injection for participants suffering from elevated anal canal pressure

Timeline

• Start date: 2024-09-07
• Primary completion: 2025-09-01
• Completion: 2025-10-01
• First posted: 2024-08-09
• Last updated: 2024-10-09

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study