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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06174584

Enrollment

Registered

2023-12-18

Start date

2021-02-01

Completion date

2022-02-01

Last updated

2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Prolapse

Brief summary

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

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.

Interventions

DRUGHypertonic saline

Hypertonic saline

OTHERCow Milk

Cow Milk

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

1 Years to 12 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026