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
• Status: Completed
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

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