Different Bowel Preparations for Colonoscopy In Children
NCT ID: NCT01711437
Last Updated: 2012-11-06
Study Results
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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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2011-01-31
2013-09-30
Brief Summary
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THE AIM OF THIS STUDY IS TO COMPARE THE OVERALL COLON CLEANSING
Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
SINGLE
Study Groups
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PEG-S
polyethylene glycol 4000 solution with simethicon
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.
PEG-CS + Bisacodyl
PEG-CS is a new sulphate-free iso-osmotic formulation of PEG-4000 with citrates and simethicone
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.
PEG-ASC
polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid
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.
picoprep
sodium picosulphate plus magnesium oxide and citric acid
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
Interventions
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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.
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.
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
2 Years
18 Years
ALL
No
Sponsors
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Azienda Policlinico Umberto I
OTHER
Responsible Party
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Giovanni Di Nardo
MD
Locations
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Dipartimento di pediatria e neuropsichiatria Policlinico umberto l "università di roma la sapienza"
Roma, , Italy
Countries
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Facility Contacts
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Dipartimento di pediatria e neuropsichiatria Policlinico umberto l "università di roma la sapienza"
Role: primary
Other Identifiers
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PEG-P2
Identifier Type: -
Identifier Source: org_study_id