Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children

King Edward Medical University

Status: Completed

Conditions: Rectal Prolapse

Treatments: Procedure: injection 5% phenol in almond oil; Procedure: injection 15% hypertonic saline; Procedure: injection 50% dextrose water

Study type: Interventional

Funder types: Other

Identifiers

NCT06353230

0001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 3 to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with partial or complete rectal prolapse of either gender presenting to paediatric surgery department, Mayo Hospital Lahore, under 13 years of age.

Exclusion criteria

• Patients of rectal prolapse due to ulcerative colitis and crohn's disease documented in medical record.
• Patients with previous history of surgery on pelvic floor documented in medical record.
• Caudaequina syndrome, neural tube defects, Sacrococcygeal teratoma, Hirschsprung,s disease, congenitalmega colon and rectal polyps documented in medical record. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

Group A with 5% phenol in almond oil

Experimental group

Description:

Group A patients with rectal prolapse were given injection sclerotherapy with 5% phenol in almond oil,

Treatment:

Procedure: injection 50% dextrose water

Procedure: injection 15% hypertonic saline

Procedure: injection 5% phenol in almond oil

Group B with hypertonic saline

Active Comparator group

Description:

Group B with rectal prolapse were given injection sclerotherapy with 15% hypertonic saline

Treatment:

Procedure: injection 50% dextrose water

Procedure: injection 15% hypertonic saline

Procedure: injection 5% phenol in almond oil

Group C with 50% Dextrose water

Active Comparator group

Description:

Group C with rectal prolapse were given injection sclerotherapy with 50% Dextrose water

Treatment:

Procedure: injection 50% dextrose water

Procedure: injection 15% hypertonic saline

Procedure: injection 5% phenol in almond oil