Different Bowel Preparations for Colonoscopy In Children

Colonoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01711437
• Other study ID #: PEG-P2
• Status: Recruiting
• Phase: Phase 4
• First received: October 18, 2012
• Last updated: November 5, 2012
• Start date: January 2011
• Est. completion date: September 2013

Study information

• Verified date: October 2012
• Source: Azienda Policlinico Umberto I
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Colonoscopy

Intervention

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.
• 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

Locations

Country	Name	City	State
Italy	Dipartimento di pediatria e neuropsichiatria Policlinico umberto l "università di roma la sapienza"	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Policlinico Umberto I

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	safety	Adverse events were assessed on the day of colonoscopy by direct questioning and by telephone interview 48-96 hours after colonoscopy.	4 days	Yes
Secondary	clinical tolerabiity	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	Yes
Secondary	Compliance	Compliance was scored on a 3-point scale according to the percentage of drunk solution	On the morning of colonoscopy, immediately before the procedure	No
Secondary	Acceptability	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	No