Ain shams university
Cairo, Egypt
Location status: Recruiting
NCT Number: NCT06543979
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
Interested in participating?
Request Info4 year–16 year
All sexes
Interventional
Phase 1 / Phase 2
Cairo, Egypt
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
At least 2 of the following present at least once per week for at least 1 month:
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 criteria
laxative
Other names: lubicont
Biofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations
Botulinum toxin injection for participants suffering from elevated anal canal pressure
Time frame: 1 year
To measure the percent of the most common manometric parameters in children with chronic refractory constipation e.g dyssengeric defecation and reduced rectal sensetivity and anal sphincter dysfunction.
Time frame: 1 month
Spontaneous Bowel Movement (SBM) Frequency at Week 1,2,3 and 4 A SBM was defined as any bowel movement (BM) that does not occur within 24 hours after rescue medication use (laxative, suppository, or enema). Participants will be given a diary to complete at home where they will record all details of each SBM including the consistency of the stool and the difficulty they have in passing it.
Time frame: 3 months
Participants with chronic refractory constipation and manometry parameters showed dyssengeric defecation or hyposensitivity will receive biofeedback sessions and the investigators measure the difference in bowel management scoring tool before and after the biofeedback sessions the higher the score the worest the condition
Time frame: 1 month
Participants will receive cow milk free diet for 4 weeks and investigators measure the difference in bowel management scoring tool before and after cow milk free diet the higher the score the worest the condition
Time frame: 3 month
Participants with chronic refractory and manometric parameters showed high anal canal resting pressure will have botulinum toxin injection and investigators measure the difference in bowel management scoring tool before and after the injection the higher the score the worest the condition
Contact information is provided by the study sponsor or research team.
asmaa abdelnaby mohamed soliman, master
CONTACT
yosra mohamed mohsen awad, MD
CONTACT
Ain Shams University
Other
The Diagnostic Value of Anorectal Manometry in Pediatric Chronic Refractory Constipation With or Without Fecal Incontinence
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