NCT01711437

Different Bowel Preparations for Colonoscopy In Children

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Azienda Policlinico Umberto I · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colonoscopy

Interventions

Type	Name	Description
DEVICE	PEG-4000 with citrates and simethicone	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.
DEVICE	polyethylene glycol 4000 solution with simethicon	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.
DEVICE	polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid	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.
DEVICE	sodium picosulphate plus magnesium oxide and citric acid	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

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2012-10-22
• Last updated: 2012-11-06

Locations

1 site across 1 country: Italy