Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children (Prolapse)

April 11, 2024 updated by: Muhammad Sharif, King Edward Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

93

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • department of pediatric surgery King Edward Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A with 5% phenol in almond oil
Group A patients with rectal prolapse were given injection sclerotherapy with 5% phenol in almond oil,
Procedure: injection 5% phenol in almond oil
Group A were given 5% phenol in almond oil
Other Names:
  • sclerotherapy wiyh 5% phenol in almond oil
Procedure: injection 15% hypertonic saline
Group B were given hypertonic saline
Other Names:
  • sclerotherapy with hypertonic saline
Procedure: injection 50% dextrose water
group C were given 50% dextrose water
Other Names:
  • sclerotherapy with 50% dexrose water
Active Comparator: Group B with hypertonic saline
Group B with rectal prolapse were given injection sclerotherapy with 15% hypertonic saline
Procedure: injection 5% phenol in almond oil
Group A were given 5% phenol in almond oil
Other Names:
  • sclerotherapy wiyh 5% phenol in almond oil
Procedure: injection 15% hypertonic saline
Group B were given hypertonic saline
Other Names:
  • sclerotherapy with hypertonic saline
Procedure: injection 50% dextrose water
group C were given 50% dextrose water
Other Names:
  • sclerotherapy with 50% dexrose water
Active Comparator: Group C with 50% Dextrose water
Group C with rectal prolapse were given injection sclerotherapy with 50% Dextrose water
Procedure: injection 5% phenol in almond oil
Group A were given 5% phenol in almond oil
Other Names:
  • sclerotherapy wiyh 5% phenol in almond oil
Procedure: injection 15% hypertonic saline
Group B were given hypertonic saline
Other Names:
  • sclerotherapy with hypertonic saline
Procedure: injection 50% dextrose water
group C were given 50% dextrose water
Other Names:
  • sclerotherapy with 50% dexrose water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: 3 months
Re-appearance of signs and symptoms of rectal prolapse after remission will be labelled as
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Edward Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2019

Primary Completion (Actual)

October 14, 2020

Study Completion (Actual)

April 13, 2021

Study Registration Dates

First Submitted

March 31, 2024

First Submitted That Met QC Criteria

April 5, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0001 (Researcher)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Will be shared through personal request

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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