The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation

NCT07291661 | Not Yet Recruiting

• 1 other identifier: Anorectal manometry
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Anorectal manometry; Functional constipation; Pediatric chronic refractory constipation; Fecal incontinence; Biofeedback therapy; Botox injection

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

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

  Baseline

Study Arms (1)

High resolution anorectal manometry using multiuse water perfused catheter

OTHER

Solar™ GI High Resolution Anorectal Manometry with multiuse water perfused catheter

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

Interventions

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.

High resolution anorectal manometry using multiuse water perfused catheter

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University-faculty of medicine

Asyut, 71511, Egypt

Location

Related Publications (4)

• Poojari VS, Mirani S, Shetty NS, Shah I. Evaluation of constipation in children using high-resolution anorectal manometry. Trop Doct. 2021 Oct;51(4):527-531. doi: 10.1177/00494755211030362. Epub 2021 Jul 16.

  PMID: 34270377 BACKGROUND

• Rao SSC, Tetangco EP. Anorectal Disorders: An Update. J Clin Gastroenterol. 2020 Aug;54(7):606-613. doi: 10.1097/MCG.0000000000001348.

  PMID: 32692116 BACKGROUND

• Carrington EV, Scott SM, Bharucha A, Mion F, Remes-Troche JM, Malcolm A, Heinrich H, Fox M, Rao SS; International Anorectal Physiology Working Group and the International Working Group for Disorders of Gastrointestinal Motility and Function. Expert consensus document: Advances in the evaluation of anorectal function. Nat Rev Gastroenterol Hepatol. 2018 May;15(5):309-323. doi: 10.1038/nrgastro.2018.27. Epub 2018 Apr 11.

  PMID: 29636555 BACKGROUND

• Koppen IJN, Vriesman MH, Saps M, Rajindrajith S, Shi X, van Etten-Jamaludin FS, Di Lorenzo C, Benninga MA, Tabbers MM. Prevalence of Functional Defecation Disorders in Children: A Systematic Review and Meta-Analysis. J Pediatr. 2018 Jul;198:121-130.e6. doi: 10.1016/j.jpeds.2018.02.029. Epub 2018 Apr 12.

  PMID: 29656863 BACKGROUND

MeSH Terms

Conditions

Constipation; Fecal Incontinence

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Naglaa H. Ibrahim, Professor

  Assiut University- Faculty of medicine

  STUDY DIRECTOR

• Naglaa S. Mohamed, A. professor

  Assiut University- Faculty of medicine

  STUDY CHAIR

• Rehab I. Hassan, Lecturer

  Assiut University- Faculty of medicine

  STUDY CHAIR

Central Study Contacts

Yasser M. Abd Elaal, Master

CONTACT

+201021356722; Yasser.mohamed412@gmail.com

Nagla H. Ibrahim, Professor

CONTACT

+20111187223

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: A descriptive cross-sectional study

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)