Different Bowel Preparations for Colonoscopy In Children

Azienda Policlinico Umberto I

Status and phase: Unknown; Phase 4

Conditions: Colonoscopy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01711437

PEG-P2

Details and patient eligibility

About

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

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

400 participants in 4 patient groups

PEG-S

Experimental group

Description:

polyethylene glycol 4000 solution with simethicon

Treatment:

Device: polyethylene glycol 4000 solution with simethicon

PEG-CS + Bisacodyl

Experimental group

Description:

PEG-CS is a new sulphate-free iso-osmotic formulation of PEG-4000 with citrates and simethicone

Treatment:

Device: PEG-4000 with citrates and simethicone

PEG-ASC

Experimental group

Description:

polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid

Treatment:

Device: polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid

picoprep

Experimental group

Description:

sodium picosulphate plus magnesium oxide and citric acid

Treatment:

Device: sodium picosulphate plus magnesium oxide and citric acid