Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children

Not Applicable

Completed

• Conditions: Rectal Prolapse
• Interventions: Procedure: injection 5% phenol in almond oil; Procedure: injection 15% hypertonic saline; Procedure: injection 50% dextrose water

• Registration Number: NCT06353230
• Lead Sponsor: King Edward Medical University

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 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.

Study Timeline

• Study Start: 2019-10-15
• Primary Completion: 2020-10-14
• Study Completion: 2021-04-13
• Study First Submitted: 2024-03-31
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-05
• Study First Posted: 2024-04-09
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

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. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A with 5% phenol in almond oil	injection 15% hypertonic saline	Group A patients with rectal prolapse were given injection sclerotherapy with 5% phenol in almond oil,
Group A with 5% phenol in almond oil	injection 5% phenol in almond oil	Group A patients with rectal prolapse were given injection sclerotherapy with 5% phenol in almond oil,
Group A with 5% phenol in almond oil	injection 50% dextrose water	Group A patients with rectal prolapse were given injection sclerotherapy with 5% phenol in almond oil,
Group C with 50% Dextrose water	injection 5% phenol in almond oil	Group C with rectal prolapse were given injection sclerotherapy with 50% Dextrose water
Group C with 50% Dextrose water	injection 15% hypertonic saline	Group C with rectal prolapse were given injection sclerotherapy with 50% Dextrose water
Group C with 50% Dextrose water	injection 50% dextrose water	Group C with rectal prolapse were given injection sclerotherapy with 50% Dextrose water
Group B with hypertonic saline	injection 5% phenol in almond oil	Group B with rectal prolapse were given injection sclerotherapy with 15% hypertonic saline
Group B with hypertonic saline	injection 15% hypertonic saline	Group B with rectal prolapse were given injection sclerotherapy with 15% hypertonic saline
Group B with hypertonic saline	injection 50% dextrose water	Group B with rectal prolapse were given injection sclerotherapy with 15% hypertonic saline

Primary Outcome Measures

Name	Time	Method
Recurrence	3 months	Re-appearance of signs and symptoms of rectal prolapse after remission will be labelled as

Secondary Outcome Measures

Name	Time	Method
fecal incontinence	3 months	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

Trial Locations

Locations (1)

department of pediatric surgery King Edward Medical University; 🇵🇰 Lahore, Punjab, Pakistan