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Completed

NCT Number: NCT06353230

Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children

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.

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Key information

Age range

3 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

department of pediatric surgery King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

injection 5% phenol in almond oil

Procedure

Group A were given 5% phenol in almond oil

Other names: sclerotherapy wiyh 5% phenol in almond oil

injection 15% hypertonic saline

Procedure

Group B were given hypertonic saline

Other names: sclerotherapy with hypertonic saline

injection 50% dextrose water

Procedure

group C were given 50% dextrose water

Other names: sclerotherapy with 50% dexrose water

Primary outcomes

  1. Recurrence

    Time frame: 3 months

    Re-appearance of signs and symptoms of rectal prolapse after remission will be labelled as

Secondary outcomes

  1. fecal incontinence

    Time frame: 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

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Acronym: Prolapse

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 9, 2024
Registry last updated
Apr 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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