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

December 15, 2023 updated by: Mansoor Ahmed, Shaheed Zulfiqar Ali Bhutto Medical University
To see the outcome of results of Cow Milk & Hypertonic Saline in the treatment of Rectal Prolapse in Children

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
      • Islamabad, Pakistan, 44000
        • Shaheed Zulfiqar Ali Bhutto Medical University/PIMS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cow Milk
Cow Milk was injected as sclerosing agent in one group
Other: Cow Milk
Cow Milk
Active Comparator: 15% Hypertonic Saline
Hypertonic Saline 15% used as sclerosing agent in other half.
Drug: Hypertonic saline
Hypertonic saline

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Investigators

  • Principal Investigator: Mansoor Ahmed, MBBS, Shaheed Zulfiqar Ali Bhutto Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

January 30, 2022

Study Completion (Actual)

February 1, 2022

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShaheedZABMU1234

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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