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Not yet recruiting NCT07392203

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

Early Phase I Interventional Anorectal Malformation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rectal enema using saline and glycerin mixture once daily.
Who it may be relevant to
Registry conditions: Anorectal Malformation. Basic parameters: 3 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

Detailed 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

Interventions

  • Procedure Rectal enema using saline and glycerin mixture once daily
    Rectal enema using saline \& glycerin for treatment of fecal incontinence in children

Primary outcome measures

  • 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]
  • Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4. [Time frame: 4 weeks]

Eligibility 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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Sohag university — Sohag

Identifiers

NCT: NCT07392203 · Soh-Med-25-12-13MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗