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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Ain shams university
RECRUITING
Cairo
Contact Information
Primary
asmaa abdelnaby mohamed soliman, master
samka2015.abdelnaby@gmail.com
+2001070689789
Backup
yosra mohamed mohsen awad, MD
01001831590
Time Frame
Start Date: 2024-09-07
Estimated Completion Date: 2025-10-01
Participants
Target number of participants: 60
Treatments
Other: single arm as all participant will receive the treatment
all participant will receive lubiprostone
Sponsors
Leads: Ain Shams University

This content was sourced from clinicaltrials.gov