The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation

December 5, 2025 updated by: Yasser Mohamed Abd Elaal Ahmed, Assiut University

The Role of Anorectal Manometry in Diagnosing and Guiding Management of 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Nagla H. Ibrahim, Professor
  • Phone Number: +20111187223

Study Locations

  • Egypt
      • Asyut, Egypt, 71511
        • Assiut university-Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: High resolution anorectal manometry using multiuse water perfused catheter
Solar™ GI High Resolution Anorectal Manometry with multiuse water perfused catheter
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Naglaa H. Ibrahim, Professor, Assiut University- Faculty of Medicine
  • Study Chair: Naglaa S. Mohamed, A. professor, Assiut University- Faculty of Medicine
  • Study Chair: Rehab I. Hassan, Lecturer, Assiut University- Faculty of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

December 5, 2025

First Posted (Actual)

December 18, 2025

Study Record Updates

Last Update Posted (Actual)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Anorectal manometry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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