Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353230
Status:
COMPLETED
Last Update Posted:
2024-04-15
First Post:
2024-03-31
Brief Title:
Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children
Sponsor:
King Edward Medical University
Organization:
King Edward Medical University
Study Overview
Official Title:
Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Prolapse
Brief Summary:
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
Detailed Description:
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 36 and 9o 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None