Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children

Rectal Prolapse Clinical Trial

— Prolapse  

Official title:

Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06353230
• Other study ID #: 0001
• Status: Completed
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: April 13, 2021

Study information

• Verified date: April 2024
• Source: King Edward Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: April 13, 2021
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 13 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Prolapse
• Rectal Prolapse

Intervention

Procedure:
• injection 5% phenol in almond oil
Group A were given 5% phenol in almond oil
• injection 15% hypertonic saline
Group B were given hypertonic saline
• injection 50% dextrose water
group C were given 50% dextrose water

Locations

Country	Name	City	State
Pakistan	department of pediatric surgery King Edward Medical University	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
King Edward Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence	Re-appearance of signs and symptoms of rectal prolapse after remission will be labelled as	3 months
Secondary	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	3 months