NCT06353230

Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: King Edward Medical University · Academic / Other
• Sex: All
• Age: 3 Years – 13 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Rectal Prolapse

Interventions

Type	Name	Description
PROCEDURE	injection 5% phenol in almond oil	Group A were given 5% phenol in almond oil
PROCEDURE	injection 15% hypertonic saline	Group B were given hypertonic saline
PROCEDURE	injection 50% dextrose water	group C were given 50% dextrose water

Timeline

• Start date: 2019-10-15
• Primary completion: 2020-10-14
• Completion: 2021-04-13
• First posted: 2024-04-09
• Last updated: 2024-04-15

Locations

1 site across 1 country: Pakistan