Different Bowel Preparations for Colonoscopy In Children

Azienda Policlinico Umberto I400 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

SINGLE

Enrollment

400

Conditions

Colonoscopy

Interventions

PEG-4000 with citrates and simethiconeDEVICE

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.

polyethylene glycol 4000 solution with simethiconDEVICE

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.

polyethylene glycol 3350 hyper-osmotic solution with ascorbic acidDEVICE

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.

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing elective colonoscopy in our Institution between 2 and 18 years of age were recruited for this study. Exclusion Criteria: 1. requirement for urgent colonoscopy, 2. bowel obstruction, 3. known or suspected hypersensitivity to the active or other ingredients, 4. clinically significant electrolyte imbalance, 5. prior intestinal resection, 6. known metabolic, renal and cardiac disease

Locations (1)

Dipartimento di pediatria e neuropsichiatria Policlinico umberto l "università di roma la sapienza"

Roma, Italy

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: During the performance of colonoscopy

Secondary Outcomes

safety

Adverse events were assessed on the day of colonoscopy by direct questioning and by telephone interview 48-96 hours after colonoscopy.

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: On the morning of colonoscopy, immediately before the procedure

Data from ClinicalTrials.gov

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