The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorAssiut University
About this trial
This research protocol outlines a two-year descriptive cross-sectional study to investigate the role of high-resolution anorectal manometry (HRAM) in children aged 4-18 years with chronic refractory constipation.The study plans to enroll 54 patients at Ain Shams University Specialized Hospital . The study aims to identify different patterns of anorectal dysfunction (like dyssynergic defecation or rectal hyposensitivity) using standardized international protocols. A key goal is to determine if these manometry findings can directly guide specific management strategies, such as biofeedback therapy for dyssynergia or botulinum toxin injections for anal hypertension. improving outcomes for children who do not respond to standard constipation therapies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children and adolescents aged from 4 to 18 years.
Participants who have chronic refractory constipation either functional or organic with or without fecal incontinence.
Cooperative patients.
Disqualifiers
Children aged less than 4 years old.
Uncooperative patients.
Children with anal fissures or any painful conditions that interfere with the procedure.
Trial design
Design model
Single group
Treatments tested in this trial
High resolution anorectal manometry using a multiuse water perfused catheter
DeviceAccording to the international anorectal physiology working group recommendations(8): Stabilization: A 3-minute period after catheter insertion to allow anal tone to return to baseline. * Rest: Measures basal anal tone over 60 seconds. * Squeeze: Records anal pressure during voluntary contraction. Three 5-second squeezes are performed. * Long Squeeze: Evaluates anal pressure and fatigue during a single sustained 30-second contraction. * Cough: Assesses reflex anal pressure changes during two single coughs. * Push: Measures pressure changes during simulated defecation. Three 15-second pushes are performed. * RAIR (Rectoanal Inhibitory Reflex): Tests reflex anal relaxation after rapid rectal balloon distension, starting with at least 30 mL. Rectal Sensory Test: Measures rectal sensitivity by recording balloon volumes at three thresholds: first constant sensation, desire to defecate, and maximum tolerated volumes. · Balloon Expulsion: time required to expel the balloon.
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: High resolution anorectal manometry using multiuse water perfused catheterOther 1 intervention
Trial outcomes
Primary outcomes
1
Identification of anorectal manometry abnormalities in children with chronic refractory constipation, with or without fecal incontinence.
We will measure resting anal pressure, squeeze pressure, changes in rectoanal pressure during cough and during stimulated defecation, rectoanal inhibitory reflex (RAIR), and rectal sensation thresholds (first sensation, urge, maximum tolerable volume) using High resolusion anorectal manometry(HRAM) . Abnormalities will be categorized as: * Impaired or absent RAIR * Abnormal resting or squeeze sphincter pressure (outside age-adjusted norms) * Rectal sensory dysfunction (hyposensitivity or hypersensitivity) * Presence of dyssynergic defecation. And will be reported as counts and percentages.
Time frame
BaselineSecondary outcomes
1
Guiding Management of Chronic Refractory Constipation in Children Using Anorectal Manometry Findings.
Classification of anorectal manometry patterns-including dyssynergic defecation, rectal hyposensitivity, and elevated resting anal sphincter pressure-and documentation of the number of participants assigned to different management strategies including (biofeedback therapy, botulinum toxin injection) according to these findings. Patients with manometry parameters showing dyssennergic defecation or rectal hyposensitivity will receive biofeedback sessions. While Participants with manometry parameters showing high anal canal resting pressure will have botulinium toxin injections.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov
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