An interventional study of injection 5% phenol in almond oil and injection 15% hypertonic saline in Rectal Prolapse, sponsored by King Edward Medical University. Completed at 1 site in Pakistan. Open to participants aged 3 Years to 13 Years. Per ClinicalTrials.gov, last updated 2024-04-15.
Sponsored by King Edward Medical University · Not applicable, Interventional, and Treatment
Introduction Patients with rectal prolapse are treated with injection sclerotherapy, which is the most often used first-line surgical technique. Injection sclerotherapy has a success rate of 90-100% in youngsters, according to certain studies. Objective To compare the outcome of injection sclerotherapy using 5% Phenol in almond oil, 15% hypertonic saline and 50% dextrose water in the treatment of rectal prolapse in children.
Materials and Methods Study design: Randomized control trial. Setting: Paediatric surgery department, King Edward medical university, Mayo Hospital Lahore. Duration: Twelve months after approval of synopsis. Data collection procedure: After ethical approval, all the patients with rectal prolapse fulfilling inclusion criteria admitted. Routine history, thorough clinical examination and routine preoperative investigations was done. Patients were randomly allocated to group A, B or C using the lottery method. Group A patients were given injection sclerotherapy with 5% phenol in almond oil; Group B patients were given injection sclerotherapy with 15% hypertonic saline and group C patients were given injection sclerotherapy with 50% dextrose water solution. Under general anesthesia and patient in lithotomy position, 2-3 ml of sclerosing agent was injected into the submucosa at 3 sites around the circumference preferably at 3,6 and 9'o' clock positions about 2-3 cm above dentate line. The injection was performed under vision, using a speculum while LP needle was passed through the perianal skin. All patients were kept under observation during the hospital stay and discharged on same day and followed on week 1 and after 3 months for recurrence of rectal prolapse, fecal incontinence, perianal abscess and anal stenosis according to the operational definition.
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's enrollment of 93 is above the median of 55 across 34 interventional studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →King Edward Medical University is the lead sponsor of 82 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
Group A patients with rectal prolapse were given injection sclerotherapy with 5% phenol in almond oil,
Procedure: injection 5% phenol in almond oil · Procedure: injection 15% hypertonic saline · Procedure: injection 50% dextrose water
Group B with rectal prolapse were given injection sclerotherapy with 15% hypertonic saline
Procedure: injection 5% phenol in almond oil · Procedure: injection 15% hypertonic saline · Procedure: injection 50% dextrose water
Group C with rectal prolapse were given injection sclerotherapy with 50% Dextrose water
Procedure: injection 5% phenol in almond oil · Procedure: injection 15% hypertonic saline · Procedure: injection 50% dextrose water
Group A were given 5% phenol in almond oil
Also known as: sclerotherapy wiyh 5% phenol in almond oil
Group B were given hypertonic saline
Also known as: sclerotherapy with hypertonic saline
group C were given 50% dextrose water
Also known as: sclerotherapy with 50% dexrose water
Recurrence
Re-appearance of signs and symptoms of rectal prolapse after remission will be labelled as
Time frame: 3 months
fecal incontinence
Kelly Score will be used to assess fecal incontinence. Kelly score includes 3 parameters; occurrence of accidents, soiling and anal sphincter action. Each parameter will be scored between 0-2 with total score of 6. Total score 5 or 6 will be labelled as good fecal continence, 3 or 4 score is fair and 0 to 2 score will be labelled as poor fecal continence
Time frame: 3 months
Plan to share: No — Will be shared through personal request
No publications or documents are linked to this record.
Ran from Oct 2019 to primary completion in Oct 2020, 11 months.
Of 18 interventional studies with no phase under Rectal Prolapse, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 94. This study's 11 months is below that.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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King Edward Medical University