Role of (Saline- Glycerin) Rectal Enema in Treatment of Fecal Incontinence in Children
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4.
研究概览
简要总结
Using saline glycerin mixture once daily in children with fecal incontinence to reach aclean child without fecal accidents the next day.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- 未提供
研究组 & 干预措施
Prospective, single-arm, single-centre interventional study by rectal enema using saline and glyceri
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.
干预措施: Rectal enema using saline and glycerin mixture once daily (Procedure)
结局指标
主要结局
Proportion of clean days (no stool accidents) during days 7-14 of titration and at week 4.
时间窗: 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.
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
Souzan ALi Mohamed
Resident of pediatric surgery
Sohag University