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

S

Shaheed Zulfiqar Ali Bhutto Medical University

Status and phase

Completed
Early Phase 1

Conditions

Rectal Prolapse

Treatments

Other: Cow Milk
Drug: Hypertonic saline

Study type

Interventional

Funder types

Other

Identifiers

NCT06174584
ShaheedZABMU1234

Details and patient eligibility

About

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

Full 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.

Enrollment

80 patients

Sex

All

Ages

1 to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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