Different Bowel Preparations for Colonoscopy In Children

NCT01711437 | Unknown Phase 4 DMC

• 1 other identifier: PEG-P2
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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

Conditions

Colonoscopy

Keywords

colonoscopy; colon cleansing; children; age 2 -18 years

Outcome Measures

Primary Outcomes (1)

• 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).

  During the performance of colonoscopy

Secondary Outcomes (4)

• safety

  4 days

• clinical tolerabiity

  On the morning of colonoscopy, immediately before the procedure

• Compliance

  On the morning of colonoscopy, immediately before the procedure

• Acceptability

  On the morning of colonoscopy, immediately before the procedure

Study Arms (4)

PEG-S

EXPERIMENTAL

polyethylene glycol 4000 solution with simethicon

Device: polyethylene glycol 4000 solution with simethicon

PEG-CS + Bisacodyl

EXPERIMENTAL

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

Device: PEG-4000 with citrates and simethicone

PEG-ASC

EXPERIMENTAL

polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid

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

picoprep

EXPERIMENTAL

sodium picosulphate plus magnesium oxide and citric acid

Device: sodium picosulphate plus magnesium oxide and citric acid

Interventions

PEG-4000 with citrates and simethicone DEVICE

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.

Also known as: lovol-esse

PEG-CS + Bisacodyl

polyethylene glycol 4000 solution with simethicon DEVICE

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.

Also known as: selg-esse

PEG-S

polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid DEVICE

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.

Also known as: moviprep

PEG-ASC

sodium picosulphate plus magnesium oxide and citric acid DEVICE

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

Also known as: Picoprep

picoprep

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients undergoing elective colonoscopy in our Institution between 2 and 18 years of age were recruited for this study.

You may not qualify if:

• requirement for urgent colonoscopy,
• bowel obstruction,
• known or suspected hypersensitivity to the active or other ingredients,
• clinically significant electrolyte imbalance,
• prior intestinal resection,
• known metabolic, renal and cardiac disease

Sponsors & Collaborators

• Azienda Policlinico Umberto I: lead

Study Sites (1)

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

Roma, 00161, Italy

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: January 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 6, 2012

Record last verified: 2012-10

Locations

IT (1)