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

NCT ID: NCT06174584

Last Updated: 2023-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Rectal Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Cow Milk

Cow Milk was injected as sclerosing agent in one group

Group Type ACTIVE_COMPARATOR

Cow Milk

Intervention Type OTHER

Cow Milk

15% Hypertonic Saline

Hypertonic Saline 15% used as sclerosing agent in other half.

Group Type ACTIVE_COMPARATOR

Hypertonic saline

Intervention Type DRUG

Hypertonic saline

Interventions

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Hypertonic saline

Hypertonic saline

Intervention Type DRUG

Cow Milk

Cow Milk

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shaheed Zulfiqar Ali Bhutto Medical University

OTHER

Sponsor Role lead

Responsible Party

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Mansoor Ahmed

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mansoor Ahmed, MBBS

Role: PRINCIPAL_INVESTIGATOR

Shaheed Zulfiqar Ali Bhutto Medical University

Locations

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Shaheed Zulfiqar Ali Bhutto Medical University/PIMS

Islamabad, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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ShaheedZABMU1234

Identifier Type: -

Identifier Source: org_study_id