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The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation

NCT07291661 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2025-12-18

No results posted yet for this study

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.

Conditions

  • Refractory Constipation
  • Fecal Incontinence in Children

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.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Naglaa H. Ibrahim, Professor · Assiut University- Faculty of medicine

  • Naglaa S. Mohamed, A. professor · Assiut University- Faculty of medicine

  • Rehab I. Hassan, Lecturer · Assiut University- Faculty of medicine

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07291661 on ClinicalTrials.gov