Clinical trial

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

NCT06174584

Name

ShaheedZABMU1234

Description

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

Trial arms

Trial start

2021-02-01

Estimated PCD

2022-01-30

Trial end

2022-02-01

Status

Completed

Phase

Early phase I

Treatment

Hypertonic saline

Arms:

15% Hypertonic Saline

Cow Milk

Arms:

Cow Milk

Size

Primary endpoint

recurrence (as described by parent s during follow up)

1 year

Number of participants with fecal incontinence (as described by parents during follow up)

1 year

Number of participants with anal stenosis (on clinical examination)

1 year

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 80, 'type': 'ACTUAL'}}

Updated at

2023-12-18

1 organization

1 product

1 indication

Organization

Shaheed Zulfiqar Ali Bhutto Medical University

Product

Hypertonic saline

Indication

Rectal Prolapse