Anorectal Manometery in Pediatric Chronic Refractory Constipation

NCT ID: NCT06543979

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-07
• Study Completion Date: 2025-10-01

Brief 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

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.

Conditions

Chronic Constipation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm as all participant will receive the treatment

all participant will receive lubiprostone

Group Type: OTHER

lubiprostone , single arm

Intervention Type: DRUG

laxative

biofeed back sessions

Intervention Type: PROCEDURE

Biofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations

botox injection

Intervention Type: PROCEDURE

Botulinum toxin injection for participants suffering from elevated anal canal pressure

Interventions

lubiprostone , single arm

laxative

Intervention Type: DRUG

biofeed back sessions

Biofeedback for participants with dyssynergic defecation and participants with reduced rectal sensations

Intervention Type: PROCEDURE

botox injection

Botulinum toxin injection for participants suffering from elevated anal canal pressure

Intervention Type: PROCEDURE

Other Intervention Names

lubicont

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

asmaa abdelnaby

assistant lecturer of pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

asmaa abdelnaby mohamed soliman, master

Role: PRINCIPAL_INVESTIGATOR

assistant lecturer

Locations

Ain shams university

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

asmaa abdelnaby mohamed soliman, master

Role: CONTACT

samka2015.abdelnaby@gmail.com

+2001070689789

yosra mohamed mohsen awad, MD

Role: CONTACT

01001831590

Facility Contacts

Asmaa Abdelnaby, Master

Role: primary

Samka2015.abdelnaby@gmail.com

01070689789

Other Identifiers

manometery in constipation

Identifier Type: -

Identifier Source: org_study_id