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临床试验/NCT07291661
NCT07291661尚未招募不适用

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

Assiut University2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
54
试验地点
2
主要终点
Identification of anorectal manometry abnormalities in children with chronic refractory constipation, with or without fecal incontinence.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
4 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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

时间窗: 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.

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasser Mohamed Abd Elaal Ahmed

Doctor

Assiut University

研究点 (2)

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