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

Early Phase 1

Completed

• Conditions: Rectal Prolapse
• Interventions: Other: Cow Milk; Drug: Hypertonic saline

• Registration Number: NCT06174584
• Lead Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2021-02-01
• Primary Completion: 2022-01-30
• Study Completion: 2022-02-01
• Study First Submitted: 2023-11-28
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cow Milk	Cow Milk	Cow Milk was injected as sclerosing agent in one group
15% Hypertonic Saline	Hypertonic saline	Hypertonic Saline 15% used as sclerosing agent in other half.

Primary Outcome Measures

Name	Time	Method
recurrence (as described by parent s during follow up)	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)	1 year	Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Number of participants with anal stenosis (on clinical examination)	1 year	Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse

Trial Locations

Locations (1)

Shaheed Zulfiqar Ali Bhutto Medical University/PIMS; 🇵🇰 Islamabad, Pakistan