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The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation

A

Assiut University

Status

Not yet enrolling

Conditions

Refractory Constipation
Fecal Incontinence in Children

Treatments

Device: High resolution anorectal manometry using a multiuse water perfused catheter

Study type

Interventional

Funder types

Other

Identifiers

NCT07291661
Anorectal manometry

Details and patient eligibility

About

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.

Full description

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.

Enrollment

54 estimated patients

Sex

All

Ages

4 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

54 participants in 1 patient group

High resolution anorectal manometry using multiuse water perfused catheter
Other group
Description:
Solar™ GI High Resolution Anorectal Manometry with multiuse water perfused catheter
Treatment:
Device: High resolution anorectal manometry using a multiuse water perfused catheter

Trial contacts and locations

1

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Central trial contact

Yasser M. Abd Elaal, Master; Nagla H. Ibrahim, Professor

Data sourced from clinicaltrials.gov

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