RecruitingPhase 1Phase 2NCT06543979

Anorectal Manometery in Pediatric Chronic Refractory Constipation

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


Sponsor

Ain Shams University

Enrollment

60 participants

Start Date

Sep 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 4 YearsMax Age: 16 Years

Inclusion Criteria11

  • 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:
  • 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.
  • 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.

Exclusion Criteria3

  • participants who have anorectal malformation
  • participants who have neurological disease affecting lower limbs
  • Has a history of hypersensitivity or allergies to lubiprostone

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Interventions

DRUGlubiprostone , single arm

laxative

PROCEDUREbiofeed back sessions

Biofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations

PROCEDUREbotox injection

Botulinum toxin injection for participants suffering from elevated anal canal pressure


Locations(1)

Ain shams university

Cairo, Egypt

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NCT06543979


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