Anorectal Manometery in Pediatric Chronic Refractory Constipation

Launched by AIN SHAMS UNIVERSITY · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a special test called anorectal manometry to better understand chronic constipation in children. Chronic constipation is when kids have a hard time going to the bathroom, even when they are using medications to help. The trial aims to find out if the constipation is caused by problems with the muscle that controls bowel movements, issues with feeling when it's time to go, or if the muscles in the pelvic area aren't working together properly.

Children aged 4 to 16 who have been diagnosed with functional constipation and are having ongoing issues, despite treatment, may be eligible to participate. To qualify, they must have specific symptoms, like having fewer than two bowel movements a week or experiencing painful bowel movements. Participants will need to keep a diary about their symptoms and fill out a questionnaire. This study is currently looking for participants, and parents will need to give their consent for their child to join. Overall, this trial could help doctors learn more about effective treatments for children suffering from chronic constipation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Children and adolescents aged from 4 to 16 years.
• • 2. 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).
• • 3. 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