Comparison of Cow Milk and 15% Hypertonic Saline in the Treatment of Rectal Prolapse in Children

Study Overview
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Brief Summary
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To see the outcome of results of Cow Milk & Hypertonic Saline in the treatment of Rectal Prolapse in Children

Detailed Description
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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.

Official Title
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Comparison of Cow Milk and 15% Hypertonic Saline in the Treatment of Rectal Prolapse in Children

Conditions
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Rectal Prolapse

Intervention / Treatment
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* Drug: Hypertonic saline
* Other: Cow Milk


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All children with Grade I and II rectal prolapse Age <12 years Both genders Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cow Milk<br>Cow Milk was injected as sclerosing agent in one group | Other: Cow Milk<br>* Cow Milk<br>|
| Active Comparator: 15% Hypertonic Saline<br>Hypertonic Saline 15% used as sclerosing agent in other half. | Drug: Hypertonic saline<br>* Hypertonic saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence (as described by parent s during follow up) | Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse | 1 year | 
| Number of participants with fecal incontinence (as described by parents during follow up) | Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse | 1 year | 
| Number of participants with anal stenosis (on clinical examination) | Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse | 1 year |