An Early Phase 1 interventional study of Hypertonic saline and Cow Milk in Rectal Prolapse, sponsored by Shaheed Zulfiqar Ali Bhutto Medical University. Completed at 1 site in Pakistan. Open to participants aged 1 Year to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-18.
Sponsored by Shaheed Zulfiqar Ali Bhutto Medical University · Early Phase 1, Interventional, and Treatment
To see the outcome of results of Cow Milk \& Hypertonic Saline in the treatment of Rectal Prolapse in Children
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.
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's enrollment of 80 is above the median of 55 across 34 interventional studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →Shaheed Zulfiqar Ali Bhutto Medical University is the lead sponsor of 37 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Cow Milk was injected as sclerosing agent in one group
Other: Cow Milk
Hypertonic Saline 15% used as sclerosing agent in other half.
Drug: Hypertonic saline
Hypertonic saline
Cow Milk
recurrence (as described by parent s during follow up)
Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Time frame: 1 year
Number of participants with fecal incontinence (as described by parents during follow up)
Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Time frame: 1 year
Number of participants with anal stenosis (on clinical examination)
Comparison of Cow Milk vs 15% Hypertonic Saline for rectal prolapse
Time frame: 1 year
Plan to share: No — Confidentiality
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Shaheed Zulfiqar Ali Bhutto Medical University