Role of (Saline- Glycerin) Rectal Enema in Treatment of Fecal Incontinence in Children

Sohag University

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Anorectal Malformation

Treatments: Procedure: Rectal enema using saline and glycerin mixture once daily

Study type: Interventional

Funder types: Other

Identifiers

NCT07392203

Soh-Med-25-12-13MS

Details and patient eligibility

About

Using saline glycerin mixture once daily in children with fecal incontinence to reach aclean child without fecal accidents the next day.

Full description

Child lies on Lt lateral position. Foley catheter inserted to thr rectum and inflated Instillation of saline glycerin mixture. Child hold it for 15 minutes Foley catheter removed Child stay in bathroom for 45 min

Enrollment: 30 estimated patients

Sex: All

Ages: 3 to 16 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

InclusioChildren ≥3 and ≤16 years with Fecal incontinence (≥1 episode/week) due to corrected anorectal malformation (ARM), Hirschsprung disease after pull-through, perineal trauma, spinal anomalies/neurogenic bowel, or functional constipation with overflow incontinence.

Ability to participate in a structured bowel-management regimen at home.

Caregiver availability for training and daily administration. n Criteria:

- Age <3 years. symptomatic anal stricture, or other anatomic issues requiring surgical correction before bowel management.

Current enterocolitis, Active proctitis, painful fissure with bleeding, or severe perianal dermatitis precluding safe catheterization.

Chronic kidney disease, unstable cardiac disease, or known electrolyte imbalance.

Hypersensitivity/intolerance to glycerin; prior severe reaction to enemas. Stoma in situ or ACE dependence (separate pathway).

Exclusion Criteria:

-

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Prospective, single-arm, single-centre interventional study by rectal enema using saline and glyceri

Experimental group

Description:

Prospective, single-arm, single-centre interventional study conducted in the Pediatric Surgery Department, Sohag University Hospitals. The protocol adheres to contemporary bowel-management frameworks for pediatric fecal incontinence with daily retrograde enemas and radiographic/clinical titration.

Treatment:

Procedure: Rectal enema using saline and glycerin mixture once daily