Different Bowel Preparations for Colonoscopy In Children

November 5, 2012 updated by: Giovanni Di Nardo, Azienda Policlinico Umberto I

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Roma, Italy, 00161
        • Recruiting
        • Dipartimento di pediatria e neuropsichiatria Policlinico Umberto l "Università di Roma la Sapienza"
        • Contact:
          • Dipartimento di pediatria e neuropsichiatria Policlinico umberto l "università di roma la sapienza"
          • Phone Number: 0649979326
          • Email: giovanni.dinardo@uniroma1.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEG-S
polyethylene glycol 4000 solution with simethicon
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.
Other Names:
  • selg-esse
EXPERIMENTAL: PEG-CS + Bisacodyl
PEG-CS is a new sulphate-free iso-osmotic formulation of PEG-4000 with citrates and simethicone
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.
Other Names:
  • lovol-esse
EXPERIMENTAL: PEG-ASC
polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid
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.
Other Names:
  • moviprep
EXPERIMENTAL: picoprep
sodium picosulphate plus magnesium oxide and citric acid
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
Other Names:
  • Picoprep

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy
Time Frame: 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).
During the performance of colonoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety
Time Frame: 4 days
Adverse events were assessed on the day of colonoscopy by direct questioning and by telephone interview 48-96 hours after colonoscopy.
4 days
clinical tolerabiity
Time Frame: 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
On the morning of colonoscopy, immediately before the procedure
Compliance
Time Frame: On the morning of colonoscopy, immediately before the procedure
Compliance was scored on a 3-point scale according to the percentage of drunk solution
On the morning of colonoscopy, immediately before the procedure
Acceptability
Time Frame: 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.
On the morning of colonoscopy, immediately before the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Policlinico Umberto I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ANTICIPATED)

September 1, 2013

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

October 18, 2012

First Submitted That Met QC Criteria

October 19, 2012

First Posted (ESTIMATE)

October 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 6, 2012

Last Update Submitted That Met QC Criteria

November 5, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEG-P2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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