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NCT Number: NCT07392203

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

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

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Key information

Conditions

Anorectal Malformation Anorectal Malformations Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Sohag university

Sohag, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Rectal enema using saline and glycerin mixture once daily

Procedure

Rectal enema using saline & glycerin for treatment of fecal incontinence in children

Primary outcomes

  1. Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4.

    Time frame: Follow up after 4 weeks and after 12 weeks

  2. Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4.

    Time frame: 4 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Suzan Ali Mohammed, Resident of pediatric surgery

CONTACT

[email protected]

01143847284

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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