The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation
NCT ID: NCT07291661
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
54 participants
INTERVENTIONAL
2026-01-01
2027-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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High resolution anorectal manometry using multiuse water perfused catheter
Solar™ GI High Resolution Anorectal Manometry with multiuse water perfused catheter
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Participants who have chronic refractory constipation either functional or organic with or without fecal incontinence.
3. Cooperative patients.
Exclusion Criteria
2. Uncooperative patients.
3. Children with anal fissures or any painful conditions that interfere with the procedure.
4 Years
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Yasser Mohamed Abd Elaal Ahmed
Doctor
Principal Investigators
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Naglaa H. Ibrahim, Professor
Role: STUDY_DIRECTOR
Assiut University- Faculty of medicine
Naglaa S. Mohamed, A. professor
Role: STUDY_CHAIR
Assiut University- Faculty of medicine
Rehab I. Hassan, Lecturer
Role: STUDY_CHAIR
Assiut University- Faculty of medicine
Locations
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Assiut University-faculty of medicine
Asyut, , Egypt
Countries
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Central Contacts
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Nagla H. Ibrahim, Professor
Role: CONTACT
Phone: +20111187223
References
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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.
Rao SSC, Tetangco EP. Anorectal Disorders: An Update. J Clin Gastroenterol. 2020 Aug;54(7):606-613. doi: 10.1097/MCG.0000000000001348.
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.
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.
Other Identifiers
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Anorectal manometry
Identifier Type: -
Identifier Source: org_study_id