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

Early Phase 1CompletedNCT06174584

Shaheed Zulfiqar Ali Bhutto Medical University80 enrolled

Overview

To see the outcome of results of Cow Milk \& Hypertonic Saline in the treatment of Rectal Prolapse in Children

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Rectal Prolapse

Interventions

Hypertonic salineDRUG

Hypertonic saline

Cow MilkOTHER

Cow Milk

Eligibility

Sex: ALLMin age: 1 YearMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Shaheed Zulfiqar Ali Bhutto Medical University/PIMS

Islamabad, Pakistan

Outcomes

Primary Outcomes

recurrence (as described by parent s during follow up)

Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse

Time frame: 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

Time frame: 1 year

Number of participants with anal stenosis (on clinical examination)

Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse

Time frame: 1 year

Data from ClinicalTrials.gov

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