Status:
RECRUITING
Anorectal Manometery in Pediatric Chronic Refractory Constipation
Lead Sponsor:
Ain Shams University
Conditions:
Chronic Constipation
Eligibility:
All Genders
4-16 years
Phase:
PHASE1
PHASE2
Brief 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 inconten...
Detailed Description
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 effec...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- participants who have anorectal malformation
- participants who have neurological disease affecting lower limbs
- Has a history of hypersensitivity or allergies to lubiprostone
Key Trial Info
Start Date :
September 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06543979
Start Date
September 7 2024
End Date
October 1 2025
Last Update
October 9 2024
Active Locations (1)
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1
Ain shams university
Cairo, Egypt