Anorectal Manometery in Pediatric Chronic Refractory Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: lubiprostone , single arm, biofeed back sessions, botox injection.
- Who it may be relevant to
- Registry conditions: Chronic Constipation. Basic parameters: 4 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Diagnostic Value of Anorectal Manometry in Pediatric Chronic Refractory Constipation With or Without Fecal Incontinence
Overview
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
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 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.
Interventions
- Drug lubiprostone , single arm
laxative - Procedure biofeed back sessions
Biofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations - Procedure botox injection
Botulinum toxin injection for participants suffering from elevated anal canal pressure
Primary outcome measures
- To evaluate the manometric parameters in children with chronic refractory constipation [Time frame: 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 [Time frame: 1 month]
Secondary outcome measures (3)
- To determine the effect of biofeed back sessions in children with dyssengeric defecation and in children with rectal hyposensetivity [Time frame: 3 months]
- To determine the effect of cow milk protein free diet on chronic refractory constipation in children [Time frame: 1 month]
- To determine the effect of botulinum toxin injection in children with elevated anal canal resting pressure [Time frame: 3 month]
Eligibility criteria
Inclusion criteria
- 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 criteria
- participants who have anorectal malformation
- participants who have neurological disease affecting lower limbs
- Has a history of hypersensitivity or allergies to lubiprostone
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ain shams university — Cairo
Identifiers
NCT: NCT06543979 · manometery in constipation