Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2021-04-13

Brief Summary

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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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Detailed Description

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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.

Conditions

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Rectal Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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

Study Groups

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Group A with 5% phenol in almond oil

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

Group Type EXPERIMENTAL

injection 5% phenol in almond oil

Intervention Type PROCEDURE

Group A were given 5% phenol in almond oil

injection 15% hypertonic saline

Intervention Type PROCEDURE

Group B were given hypertonic saline

injection 50% dextrose water

Intervention Type PROCEDURE

group C were given 50% dextrose water

Group B with hypertonic saline

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

Group Type ACTIVE_COMPARATOR

injection 5% phenol in almond oil

Intervention Type PROCEDURE

Group A were given 5% phenol in almond oil

injection 15% hypertonic saline

Intervention Type PROCEDURE

Group B were given hypertonic saline

injection 50% dextrose water

Intervention Type PROCEDURE

group C were given 50% dextrose water

Group C with 50% Dextrose water

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

Group Type ACTIVE_COMPARATOR

injection 5% phenol in almond oil

Intervention Type PROCEDURE

Group A were given 5% phenol in almond oil

injection 15% hypertonic saline

Intervention Type PROCEDURE

Group B were given hypertonic saline

injection 50% dextrose water

Intervention Type PROCEDURE

group C were given 50% dextrose water

Interventions

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injection 5% phenol in almond oil

Group A were given 5% phenol in almond oil

Intervention Type PROCEDURE

injection 15% hypertonic saline

Group B were given hypertonic saline

Intervention Type PROCEDURE

injection 50% dextrose water

group C were given 50% dextrose water

Intervention Type PROCEDURE

Other Intervention Names

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sclerotherapy wiyh 5% phenol in almond oil sclerotherapy with hypertonic saline sclerotherapy with 50% dexrose water

Eligibility Criteria

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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. -

Minimum Eligible Age

3 Years

Maximum Eligible Age

13 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No