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NCT Number: NCT07291661

The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation

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.

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Key information

Conditions

Refractory Constipation Constipation Digestive System Diseases Fecal Incontinence Fecal Incontinence in Children Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University-faculty of medicine

Asyut, 71511, Egypt

About this study

Structural and functional abnormalities of the anorectum or pelvic floor have been observed in constipated children with or without fecal incontinence. Childhood functional constipation accounts for about 95% of cases, while organic causes are less than 5%.

Organic causes include Hirschsprung disease, anorectal malformations, neuromuscular disorders and metabolic causes. Functional constipation can be caused by paradoxical contraction or insufficient relaxation of the pelvic floor muscles, and/or inadequate rectal propulsive forces during defecation. According to the Rome IV criteria, functional constipation is defined separately for infants and toddlers (<4 years) and for children (≥ 4 years).

Anorectal manometry (ARM) is an objective tool used to measure pressure and sensation in the anorectum at rest, during squeezing, and during simulated evacuation. three dimensional high resolution anorectal manometry (3D-HRAM) employs an array of 256 sensors, offering a more detailed assessment of anorectal anatomy and function.

Anorectal manometry is used for the evaluation of chronic constipation by checking rectoanal coordination and rectal sensitivity, and helps exclude structural disorders. It evaluates fecal incontinence by analyzing sphincter function and rectal sensation, identifies sphincter hypertension in functional anorectal pain, and provides preoperative baseline data before surgeries affecting continence or defecation.

Treatment of childhood constipation includes both nonpharmacological approaches (education, dietary modifications, behavioral strategies, biofeedback, and pelvic floor physiotherapy) and pharmacological options (osmotic and stimulant laxatives, probiotics as well as newer medications such as prucalopride and lubiprostone). For children with persistent constipation transanal irrigation, botulinum toxin injections, neuromodulation, and surgical procedures may be considered.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children and adolescents aged from 4 to 18 years.
  • Participants who have chronic refractory constipation either functional or organic with or without fecal incontinence.
  • Cooperative patients.

Exclusion criteria

  • Children aged less than 4 years old.
  • Uncooperative patients.
  • Children with anal fissures or any painful conditions that interfere with the procedure.

Treatment and study plan

High resolution anorectal manometry using a multiuse water perfused catheter

Device

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.

Primary outcomes

  1. Identification of anorectal manometry abnormalities in children with chronic refractory constipation, with or without fecal incontinence.

    Time frame: Baseline

    We will measure resting anal pressure, squeeze pressure, changes in rectoanal pressure during cough and during stimulated defecation, rectoanal inhibitory reflex (RAIR), and rectal sensation thresholds (first sensation, urge, maximum tolerable volume) using High resolusion anorectal manometry(HRAM) .

    Abnormalities will be categorized as:

    • Impaired or absent RAIR
    • Abnormal resting or squeeze sphincter pressure (outside age-adjusted norms)
    • Rectal sensory dysfunction (hyposensitivity or hypersensitivity)
    • Presence of dyssynergic defecation. And will be reported as counts and percentages.

Secondary outcomes

  1. Guiding Management of Chronic Refractory Constipation in Children Using Anorectal Manometry Findings.

    Time frame: Baseline

    Classification of anorectal manometry patterns-including dyssynergic defecation, rectal hyposensitivity, and elevated resting anal sphincter pressure-and documentation of the number of participants assigned to different management strategies including (biofeedback therapy, botulinum toxin injection) according to these findings.

    Patients with manometry parameters showing dyssennergic defecation or rectal hyposensitivity will receive biofeedback sessions. While Participants with manometry parameters showing high anal canal resting pressure will have botulinium toxin injections.

Study contacts

Contact information is provided by the study sponsor or research team.

Nagla H. Ibrahim, Professor

CONTACT

+20111187223

Yasser M. Abd Elaal, Master

CONTACT

[email protected]

+201021356722

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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