Comparison of Cow Milk and 15% Hypertonic Saline in the Treatment of Rectal Prolapse in Children
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- recurrence (as described by parent s during follow up)
研究概览
简要总结
To see the outcome of results of Cow Milk & Hypertonic Saline in the treatment of Rectal Prolapse in Children
详细描述
Sclerotherapy is the least invasive procedure used in management of grade I/II rectal prolapse, with a success rate of around 80%, and generally considered as the first choice for uncomplicated and recurrent prolapse. Several sclerosing agents such as 15% hypertonic saline, 5% Phenol in almond oil and cow milk have been used and reported in the literature. Present study is designed to determine the efficacy of cow milk and 15% hypertonic saline in the management of children with grade I/II rectal prolapse.
All the details will be entered on the proforma which will include resolvement of rectal prolapse and which agent has adverse effects like recurrence, fecal incontinence and anal stenosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All children with Grade I and II rectal prolapse
- •Age <12 years
- •Both genders
排除标准
- •Rectal prolapse secondary to causes like ulcerative colitis and crohn's disease
- •Past surgical history on the pelvic floor,
- •Neurological diseases like rectal polyps, congenital megacolon, Hirschsprung disease, sacrococcygeal teratoma, neural tube defects, cauda equina syndrome
- •Where parents are not willing to participate in the study
研究组 & 干预措施
Cow Milk
Cow Milk was injected as sclerosing agent in one group
干预措施: Cow Milk (Other)
15% Hypertonic Saline
Hypertonic Saline 15% used as sclerosing agent in other half.
干预措施: Hypertonic saline (Drug)
结局指标
主要结局
recurrence (as described by parent s during follow up)
时间窗: 1 year
Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Number of participants with fecal incontinence (as described by parents during follow up)
时间窗: 1 year
Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Number of participants with anal stenosis (on clinical examination)
时间窗: 1 year
Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
次要结局
未报告次要终点
研究者
Mansoor Ahmed
Principal Investigator
Shaheed Zulfiqar Ali Bhutto Medical University