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PEG Versus PEG+Bisacodyl Versus Sennosides for Colon Cleansing Before Colonoscopy

NCT01531140 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2012-02-10

No results posted yet for this study

Summary

Background:

Polyethylene glycol (PEG) solution has been proven to be effective for large bowel cleansing prior to colonoscopy in children. However, the high volume of fluid and its taste sometimes lead to inappropriate cleansing of the bowel, thus search for other bowel preparation is needed.

Aim:

The efficacy and tolerability of three different bowel cleansing protocols used in children for colonoscopy: high-volume PEG compared with low-volume PEG with stimulant laxative (bisacodyl) compared with sennosides.

Methods:

Participants aged 10-18 years will be randomly assigned to receive either PEG 60 ml/kg/day or PEG 30 ml/kg/day plus oral bisacodyl 10-15 mg/day or sennosides 2mg/kg/day for 2 days prior to the colonoscopy. The outcome measures will be:bowel cleansing efficacy, scored by a blinded endoscopist using the Ottawa scale and Aronchick Scale (the mean total score, proportions of participants with excellent/good and with poor/inadequate bowel preparation), and the patient satisfaction score(0-10)with the method of preparation for the colonoscopy evaluated with the visual analog scale. Analysis will be done on an intention to treat basis.

Conditions

  • Colonoscopy Preparation

Interventions

DRUG

polyethylene glycol +Bisacodyl

Polyethylene glycol (Fortrans) p.o. 30 ml/kg/2days + Bisacodyl p.o.10-15 mg/day for 2 days

DRUG

Polyethylene glycol

Polyethylene glycol p.o.: 60 ml/kg/days

DRUG

Sennosides

Sennosides 1tbl/8kg for 2 days

Sponsors & Collaborators

  • Institute of Child Health

    collaborator OTHER

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Piotr Dziechciarz, MD · Medical University of Warsaw

  • Jaroslaw Kierkus, MD · Child Health Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01531140 on ClinicalTrials.gov