The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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 s

Первичные конечные точки

• Identification of anorectal manometry abnormalities in children with chronic refractory constipation, with or without fecal incontinence. [Срок оценки: Baseline]

Вторичные конечные точки (1)

• Guiding Management of Chronic Refractory Constipation in Children Using Anorectal Manometry Findings. [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Египет · 1 центр

• Assiut University-faculty of medicine — Asyut

Публикации

• 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
• Rao SSC, Tetangco EP. Anorectal Disorders: An Update. J Clin Gastroenterol. 2020 Aug;54(7):606-613. doi: 10.1097/MCG.0000000000001348. PMID 32692116
• 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 PMID 29636555
• 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

Идентификаторы

NCT: NCT07291661 · Anorectal manometry

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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