Идёт набор NCT06543979

Anorectal Manometery in Pediatric Chronic Refractory Constipation

Фаза I / Фаза II С лечением Chronic Constipation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: lubiprostone , single arm, biofeed back sessions, botox injection.
Кому может быть актуально: Состояния в реестре: Chronic Constipation. Базовые параметры: 4 лет — 16 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Diagnostic Value of Anorectal Manometry in Pediatric Chronic Refractory Constipation With or Without Fecal Incontinence

Обзор

Anorectal manometry and high-resolution anorectal manometry (HRAM) are becoming the investigation of choice for understanding the pathophysiology of chronic constipation with or without fecal incontenance in children in many institutions. In high resolution anorectal manometery we are able to gain information whether the symptoms are related to sphincter dysfunction, impaired sensation, or pelvic floor dyssynergia

Подробное описание

Primary objective: To assess different patterns of anorectal manometry in children with chronic refractory constipation with or without fecal incontinence.

Secondary objective: To determine the effectiveness of different modalities of treatment of chronic refractory constipation based on the anorectal findings. To assess the safety ,tolerability and effectiveness of lubiprostone in pediatric age group with chronic refractory constipation. To assess the effect of elimination of cow milk products in patient with chronic refractory constipation.

Вмешательства

Препарат lubiprostone , single arm
laxative
Процедура biofeed back sessions
Biofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations
Процедура botox injection
Botulinum toxin injection for participants suffering from elevated anal canal pressure

Первичные конечные точки

To evaluate the manometric parameters in children with chronic refractory constipation [Срок оценки: 1 year]
evaluate the efficacy of oral administration of lubiprostone 8 and 24 μg once daily for 4 weeks in participants with chronic refractory constipation [Срок оценки: 1 month]

Вторичные конечные точки (3)

To determine the effect of biofeed back sessions in children with dyssengeric defecation and in children with rectal hyposensetivity [Срок оценки: 3 months]
To determine the effect of cow milk protein free diet on chronic refractory constipation in children [Срок оценки: 1 month]
To determine the effect of botulinum toxin injection in children with elevated anal canal resting pressure [Срок оценки: 3 month]

Критерии участия

Критерии включения

Children and adolescents aged from 4 to 16 years.
Participants fulfilling Rome IV criteria for the diagnosis of functional constipation.

At least 2 of the following present at least once per week for at least 1 month:

2 or fewer defecations in the toilet per week
At least 1 episode of fecal incontinence per week
History of retentive posturing or excessive volitional stool retention
History of painful or hard bowel movements
Presence of a large fecal mass in the rectum
History of large-diameter stools that may obstruct the toilet The symptoms cannot be fully explained by another medical condition (Hyams et al., 2016).
Participants who have chronic refractory constipation. Chronic refractory constipation (CRC) is defined as children who are unable to pass stools in spite of being on maximum laxative therapy and require daily rectal stimulation in the form of enemas or suppositories to pass stools 4-Is willing and able to keep a diary on his/her own and willing and able to complete a questionnaire.

5-The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.