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

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

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Key information

Conditions

Rectal Prolapse Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases

Age range

1 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Shaheed Zulfiqar Ali Bhutto Medical University/PIMS

Islamabad, 44000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypertonic saline

Drug

Hypertonic saline

Cow milk

Other

Cow Milk

Primary outcomes

recurrence (as described by parent s during follow up)

Time frame: 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)

Time frame: 1 year

Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Number of participants with anal stenosis (on clinical examination)

Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Other

Registry information

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Dec 18, 2023
Registry last updated: Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed