Different Bowel Preparations for Colonoscopy In Children

Study Overview
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Brief Summary
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THE AIM OF THIS STUDY IS TO COMPARE THE EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN. THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING

Detailed Description
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COLONOSCOPY IS AN ESTABLISHED DIAGNOSTIC AND THERAPEUTIC TOOL IN A VARIETY OF GASTROINTESTINAL TRACT CONDITION AFFECTING CHILDREN AND ADOLESCENTs. FOR EXAMPLE: INFLAMMATORY BOWEL DISEASE, COLONIC POLYPS OR LOWER GASTROINTESTINAL TRACT BLEEDING. THE IDEAL PREPARATION SHOULD BE OF LOW VOLUME, PALATABLE AND SUCCESSFUL IN COMPLETE COLON CLEANOUT. PRIMARY AIMS OF THIS WERE TO COMPARE THE EFFICACY AND ACCEPTANCE OF FOUR METHODS OF BOWEL CLEANSING BEFORE COLONOSCOPY IN CHILDREN. SECONDARY AIMS WAS TO COMPARE THE SAFETY PROFILE OF THIS METHODS.

Official Title
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EFFICACY, TOLERABILITY, AND SAFETY OF DIFFERENT BOWEL PREPARATIONS FOR COLONOSCOPY IN CHILDREN

Conditions
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Colonoscopy

Intervention / Treatment
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* Device: PEG-4000 with citrates and simethicone
* Device: polyethylene glycol 4000 solution with simethicon
* Device: polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid
* Device: sodium picosulphate plus magnesium oxide and citric acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective colonoscopy in our Institution between 2 and 18 years of age were recruited for this study. Exclusion Criteria: requirement for urgent colonoscopy, bowel obstruction, known or suspected hypersensitivity to the active or other ingredients, clinically significant electrolyte imbalance, prior intestinal resection, known metabolic, renal and cardiac disease

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG-S<br>polyethylene glycol 4000 solution with simethicon | Device: polyethylene glycol 4000 solution with simethicon<br>* patients received a polyethylene glycol 4000 solution with simethicon (Selg Esse) starting at 3:00 p.m. the day before the colonoscopy at a dose of 100 ml/Kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours.<br>* Other names: selg-esse;|
| Experimental: PEG-CS + Bisacodyl<br>PEG-CS is a new sulphate-free iso-osmotic formulation of PEG-4000 with citrates and simethicone | Device: PEG-4000 with citrates and simethicone<br>* 1-4 bisacodyl 5-mg tablets (Lovoldyl) at 16:00, followed 2-3 hours later by 50 ml/kg (maximum 2 L) of PEG-CS solution. The patients were instructed to drink all solution in about 2-3 hours.<br>* Other names: lovol-esse;|
| Experimental: PEG-ASC<br>polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid | Device: polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid<br>* patients received a polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid (Moviprep) a dose of 50 ml/Kg (maximum 2 L) with 25 ml/kg additional clear fluid after completing solution intake.<br>* Other names: moviprep;|
| Experimental: picoprep<br>sodium picosulphate plus magnesium oxide and citric acid | Device: sodium picosulphate plus magnesium oxide and citric acid<br>* patients received two sachets of sodium picosulphate plus magnesium oxide and citric acid (Picoprep), each diluted in 150 ml of water, at 14:00 and 6 hours later in the evening prior to the colonoscopy. Intake of at least 40-50 ml/kg of clear fluids<br>* Other names: Picoprep;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | Preparation efficacy was evaluated by the blinded endoscopist according to the Boston Bowel Preparation scale (BBPS) consisting of four-point scoring system. The total score ranging from 0 to 9 was divided into four different classes: excellent cleansing (total score 8-9), good cleansing (total score 6-7), poor cleansing (total score 4-5) and inadequate cleansing (total score 0-3). | During the performance of colonoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety | Adverse events were assessed on the day of colonoscopy by direct questioning and by telephone interview 48-96 hours after colonoscopy. | 4 days | 
| clinical tolerabiity | Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort | On the morning of colonoscopy, immediately before the procedure | 
| Compliance | Compliance was scored on a 3-point scale according to the percentage of drunk solution | On the morning of colonoscopy, immediately before the procedure | 
| Acceptability | The easiness of taking or swallowing the solution was graded according to the following scale: very severe distress = 4, severe distress = 3, moderate distress = 2, mild distress = 1, no distress = 0. | On the morning of colonoscopy, immediately before the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colonoscopy, colon cleansing, children, age 2 -18 years