An Early Phase 1 interventional study of Rectal enema using saline and glycerin mixture once daily in Anorectal Malformation, sponsored by Sohag University. Not yet recruiting at 1 site in Egypt. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Sohag University · Early Phase 1, Interventional, and Treatment
Using saline glycerin mixture once daily in children with fecal incontinence to reach aclean child without fecal accidents the next day.
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
30 studies on the registry are indexed under Anorectal Malformations; 10 are open to participants now.
This study's planned enrollment of 30 is close to the median of 30 across 12 interventional studies indexed under Anorectal Malformations.
Browse Anorectal Malformations studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
/intolerance to glycerin; prior severe reaction to enemas. Stoma in situ or ACE dependence (separate pathway).
Exclusion Criteria:
-
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: Rectal enema using saline and glycerin mixture once daily
Rectal enema using saline \& glycerin for treatment of fecal incontinence in children
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
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2026; primary completion for Jun 2026, 4 months later.
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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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