Меню
Набор по приглашению NCT06924957

Influence of Body Position on the Defecation Model During Anorectal Manometry.

— Наблюдательное Constipation Children Anorectal Disorder

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: 3D HRAM.
Кому может быть актуально
Состояния в реестре: Constipation, Children, Anorectal Disorder. Базовые параметры: 4 лет — 18 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
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Influence of Body Position on the Defecation Model Measured During High Resolution Anorectal Manometry in Children- a Control Study.

Обзор

Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Resent studies suggest that the position in which 3D HRAM is performed should be changed. So far, no scientific research has been performed in children that directly compares both positions. The reference values of registered pressures during 3D HRAM in people without complaints were not specified, which would allow for a more precise diagnosis of patients with an incorrect defecation model and precise selection of patients who could benefit from biofeedback therapy.

Подробное описание

Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry in both- sitted and lying position.

During anorectal manometry conventional manometric parameters will be recorded, such as resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded.

Вмешательства

  • Другое 3D HRAM
    The test will be performed both in supine and sitting position successively, using 3D HR-ARM. Resting, squeeze pressures, and bear down manoeuvre variables will be obtained. Diagnosis of dyssynergic defecation requires \< 20% relaxation of anal sphincter and/or intrarectal pressure\>40 mmHg during bear down manoeuvre.

Первичные конечные точки

  • DD frequency [Срок оценки: 1 day]
Вторичные конечные точки (3)
  • Values of pressures obtained during anorectal manometry [Срок оценки: 1 day]
  • Values of mean anal canal length [Срок оценки: 1 day]
  • Percentage of anal relaxation rate [Срок оценки: 1 day]

Критерии участия

Inclusion criteria - the study group:

  • age from 5 to 18 years old
  • functional constipation diagnosed on the basis of Rome IV criteria
  • parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent

Inclusion criteria - the control group:

  • age from 5 to 18 years old
  • no lower gastrointestinal symptoms
  • parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent

Exclusion criteria - the study group and the control group:

  • undergone surgeries due to congenital anomalies in the lower gastrointestinal tract
  • inflammatory bowel diseases or inflammation of the large intestine with a different aetiology
  • anal fissure, inflammation of the anal area or other conditions which, in the opinion of the researcher, could affect the functioning of the distal gastrointestinal tract

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Польша · 1 центр
  • The Department of Paediatric Gastroenterology and Nutrition, Warsaw Medical University — Warsaw

Публикации

  • Rao SS, Kavlock R, Rao S. Influence of body position and stool characteristics on defecation in humans. Am J Gastroenterol. 2006 Dec;101(12):2790-6. doi: 10.1111/j.1572-0241.2006.00827.x. Epub 2006 Oct 6. PMID 17026568
  • Su H, Peng LH, Sun G, Yang YS, Wu J, Jiang GJ, Ge H. Effect of different body position on anorectal manometry for chronic constipation patients. Eur Rev Med Pharmacol Sci. 2019 Oct;23(19):8493-8500. doi: 10.26355/eurrev_201910_19162. PMID 31646580
  • Wu GJ, Xu F, Lin L, Pasricha PJ, Chen JDZ. Anorectal manometry: Should it be performed in a seated position? Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12997. Epub 2016 Dec 1. PMID 27910245
  • Coss-Adame E, Rao SS, Valestin J, Ali-Azamar A, Remes-Troche JM. Accuracy and Reproducibility of High-definition Anorectal Manometry and Pressure Topography Analyses in Healthy Subjects. Clin Gastroenterol Hepatol. 2015 Jun;13(6):1143-50.e1. doi: 10.1016/j.cgh.2014.12.034. Epub 2015 Jan 20. PMID 25616028
  • Grossi U, Carrington EV, Bharucha AE, Horrocks EJ, Scott SM, Knowles CH. Diagnostic accuracy study of anorectal manometry for diagnosis of dyssynergic defecation. Gut. 2016 Mar;65(3):447-55. doi: 10.1136/gutjnl-2014-308835. Epub 2015 Mar 12. PMID 25765461
  • Skowronska B, Banaszkiewicz A, Banasiuk M. Influence of body position on defecation mechanics measured during high-resolution anorectal manometry in paediatric population: a protocol for case-control study. BMJ Open. 2025 Dec 31;15(12):e112928. doi: 10.1136/bmjopen-2025-112928. PMID 41475818

Идентификаторы

NCT: NCT06924957 · Banasiuk2021B

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗