Different Bowel Preparations for Colonoscopy In Children

Phase 4

• Conditions: Colonoscopy
• Interventions: Device: polyethylene glycol 4000 solution with simethicon; Device: PEG-4000 with citrates and simethicone; Device: polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid; Device: sodium picosulphate plus magnesium oxide and citric acid

• Registration Number: NCT01711437
• Lead Sponsor: Azienda Policlinico Umberto I

Brief Summary

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

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 Timeline

• Study Start: 2011-01
• Status Verified: 2012-10
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-19
• Study First Posted: 2012-10-22
• Last Update Submitted: 2012-11-05
• Last Update Posted: 2012-11-06
• Primary Completion: 2013-09
• Study Completion: 2013-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEG-S	polyethylene glycol 4000 solution with simethicon	polyethylene glycol 4000 solution with simethicon
PEG-CS + Bisacodyl	PEG-4000 with citrates and simethicone	PEG-CS is a new sulphate-free iso-osmotic formulation of PEG-4000 with citrates and simethicone
PEG-ASC	polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid	polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid
picoprep	sodium picosulphate plus magnesium oxide and citric acid	sodium picosulphate plus magnesium oxide and citric acid

Primary Outcome Measures

Name	Time	Method
Efficacy	During the performance of colonoscopy	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).

Secondary Outcome Measures

Name	Time	Method
safety	4 days	Adverse events were assessed on the day of colonoscopy by direct questioning and by telephone interview 48-96 hours after colonoscopy.
clinical tolerabiity	On the morning of colonoscopy, immediately before the procedure	Tolerability assessment was based on the recording of occurrence and severity of GI symptoms such as nausea, bloating, abdominal, pain/cramps and anal discomfort
Compliance	On the morning of colonoscopy, immediately before the procedure	Compliance was scored on a 3-point scale according to the percentage of drunk solution
Acceptability	On the morning of colonoscopy, immediately before the procedure	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.

Trial Locations

Locations (1)

Dipartimento di pediatria e neuropsichiatria Policlinico umberto l "università di roma la sapienza"; 🇮🇹 Roma, Italy