Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children

NCT06353230 | Completed DMC

• 1 other identifier: 0001
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Prolapse

Keywords

Injection Sclerotherapy; 5% Phenol in Almond oil; 15%Hypertonic saline; 50% dextrose water; Rectal prolapse

Outcome Measures

Primary Outcomes (1)

• Recurrence

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

  3 months

Secondary Outcomes (1)

• fecal incontinence

  3 months

Study Arms (3)

Group A with 5% phenol in almond oil

EXPERIMENTAL

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

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

Group B with hypertonic saline

ACTIVE COMPARATOR

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

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

Group C with 50% Dextrose water

ACTIVE COMPARATOR

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

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

Interventions

injection 5% phenol in almond oil PROCEDURE

Group A were given 5% phenol in almond oil

Also known as: sclerotherapy wiyh 5% phenol in almond oil

Group A with 5% phenol in almond oil; Group B with hypertonic saline; Group C with 50% Dextrose water

injection 15% hypertonic saline PROCEDURE

Group B were given hypertonic saline

Also known as: sclerotherapy with hypertonic saline

Group A with 5% phenol in almond oil; Group B with hypertonic saline; Group C with 50% Dextrose water

injection 50% dextrose water PROCEDURE

group C were given 50% dextrose water

Also known as: sclerotherapy with 50% dexrose water

Group A with 5% phenol in almond oil; Group B with hypertonic saline; Group C with 50% Dextrose water

Eligibility Criteria

• Age: 3 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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. -

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

department of pediatric surgery King Edward Medical University

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Rectal Prolapse

Interventions

Injections; Phenol; almond oil; Saline Solution, Hypertonic; Sclerotherapy

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Randomly allocated groupA,B or C by computer generated lottery method.and participants ,care provider and outcome assessor were kept blind by removing the drug name from injection vial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Model Details: Comparison of 5% phenol in almond oil, 15% hypertonic saline and 50% dextrose water for sclerotherapy treatment of rectal prolapse in children.

Study Record Dates

• First Submitted: March 31, 2024
• First Posted: April 9, 2024
• Study Start: October 15, 2019
• Primary Completion: October 14, 2020
• Study Completion: April 13, 2021
• Last Updated: April 15, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)