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NCT06174584 Clinical Trial

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

Rectal Prolapse Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06174584
Other study ID # ShaheedZABMU1234
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date February 1, 2021
Est. completion date February 1, 2022

Study information
Verified date December 2023
Source Shaheed Zulfiqar Ali Bhutto Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date February 1, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 12 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Hypertonic saline
Hypertonic saline
Other:
• Cow Milk
Cow Milk

Locations
Country Name City State
Pakistan Shaheed Zulfiqar Ali Bhutto Medical University/PIMS Islamabad

Sponsors (1)
Lead Sponsor Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary recurrence (as described by parent s during follow up) Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse 1 year
Primary 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
Primary Number of participants with anal stenosis (on clinical examination) Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse 1 year
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