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

February 9, 2012 updated by: Medical University of Warsaw

High-volume Polyethylene Glycol Solution (PEG) Versus Low-volume PEG Plus Stimulant Laxative Versus Sennosides for Colon Cleansing Before Colonoscopy: a Randomized, Single Blinded Study

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.

Study Overview

Detailed Description

Patients are excluded if they had known allergy to one of the tested preparations such as bisacodyl (Bisacodyl VP, ICN Polfa, Rzeszow, Poland), polyethylene glycol (Fortrans, Beaufour Ipsen Industry, Dreux, France) and/or sennoside (Xenna Extra, US Pharmacia, Wroclaw, Poland) and had disorders that make oral intake of the preparation impossible (neurological disorders, intestinal obstruction, mental retardation etc.).

Study design:

On admission day patients are allocated to one of the groups by study investigators, according to the randomization list created by an independent person using block randomization by a standard statistical program StatsDirect [version 2,3,8 (2005)] (6 patients were included in each block).

During the preparation for colonoscopy each patient are observed for procedure tolerance. On the day of endoscopy, each patient evaluated the degree of the acceptance of the method of bowel cleaning (according to visual analog scale (VAS) and the occurrence of side effects (diary). The endoscopist performing colonoscopy, blinded for the bowel preparation regimen evaluate bowel cleansing and score it, according to the Aronchick and Ottawa scale. The rate of cecum intubation, and the colonoscopy complications (defined as bowel perforation and/or significant bleeding) are analyzed in each bowel preparation group.

Study Type

Interventional

Enrollment (Actual)

240

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

      • Warsaw, Poland, 01-184
        • Warsaw Medical University
      • Warsaw, Poland, 04-730
        • Child Health Center

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

8 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children 10 - 18 years of age referred for colonoscopy
  • informed consent signed

Exclusion Criteria:

  • allergy to PEG, sennosides or bisacodyl
  • disorders that make oral intake of the preparation impossible (neurological disorders, intestinal obstruction, mental retardation etc.)

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Polyethylene glycol
Polyethylene glycol p.o.(Fortrans):60 ml/kg for 2 days
Polyethylene glycol p.o.: 60 ml/kg/days
Other Names:
  • Polyethylene glycol: Fortrans
Experimental: PEG + Bisacodyl
Polyethylene glycol p.o.(Fortrans): 30 ml/kg for 2 days + Bisacodyl p.o.: 10-15 mg/day
Polyethylene glycol (Fortrans) p.o. 30 ml/kg/2days + Bisacodyl p.o.10-15 mg/day for 2 days
Other Names:
  • Polyethylene glycol: Fortrans
Experimental: Sennosides
Sennosides: 1tbl/8kg/day for 2 days (1 tbl=8,6 mg sennosides B)
Sennosides 1tbl/8kg for 2 days
Other Names:
  • Sennosides: Xenna

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportions of participants with good or excellent bowel preparation assessed with Ottawa Scale
Time Frame: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
According to the Ottawa scale the quality of bowel preparation is estimated by adding points for the cleansing of three parts of colon (descending, transversal and ascending) and points for amount of fluid in the bowel. Score: 0-1 - excellent cleansing, 2-4 - good, 5-7 - sufficient, 8-10 - poor, 11-14 - not appropriate.
bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
proportions of participants with poor/inadequate bowel preparation assessed with Ottawa Scale
Time Frame: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
According to the Ottawa scale the quality of bowel preparation is estimated by adding points for the cleansing of three parts of colon (descending, transversal and ascending) and points for amount of fluid in the bowel. Score: 0-1 - excellent cleansing, 2-4 - good, 5-7 - sufficient, 8-10 - poor, 11-14 - not appropriate.
bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportions of participants with very good/good bowel preparation assessed with Aronchick Scale
Time Frame: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation

According to Aronchick scale preparation is estimated as:

  • very good: small amount of clear fluid is present, more than 95% mucosa is visible
  • good: small amount of clear fluid easy to suction away or flush is present, more than 90% of mucosa is visible
  • sufficient: big amount of clear fluid covering 5-25% of mucosa, more than 90% of mucosa visible
  • poor: semi-liquid stool that cannot be flushed, less than 90% of mucosa visible
  • inadequate: colonoscopy must be repeated
bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
proportions of participants with poor/inadequate bowel preparation assessed with Aronchick Scale
Time Frame: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation

According to Aronchick scale preparation is estimated as:

  • very good: small amount of clear fluid is present, more than 95% mucosa is visible
  • good: small amount of clear fluid easy to suction away or flush is present, more than 90% of mucosa is visible
  • sufficient: big amount of clear fluid covering 5-25% of mucosa, more than 90% of mucosa visible
  • poor: semi-liquid stool that cannot be flushed, less than 90% of mucosa visible
  • inadequate: colonoscopy must be repeated
bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
mean bowel preparation score assessed with Ottawa Scale
Time Frame: bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
According to the Ottawa scale the quality of bowel preparation is estimated by adding points for the cleansing of three parts of colon (descending, transversal and ascending) and points for amount of fluid in the bowel. Score: 0-1 - excellent cleansing, 2-4 - good, 5-7 - sufficient, 8-10 - poor, 11-14 - not appropriate.
bowel preparation quality with Ottawa scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
mean bowel preparation score assessed with Aronchick scale
Time Frame: bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation

According to Aronchick scale preparation is estimated as:

  • very good: small amount of clear fluid is present, more than 95% mucosa is visible
  • good: small amount of clear fluid easy to suction away or flush is present, more than 90% of mucosa is visible
  • sufficient: big amount of clear fluid covering 5-25% of mucosa, more than 90% of mucosa visible
  • poor: semi-liquid stool that cannot be flushed, less than 90% of mucosa visible
  • inadequate: colonoscopy must be repeated
bowel preparation quality with Aronchick scale is assesed during colonoscopy (3rd day of the study) by endoscopist blinded for the method of preparation
patient satisfaction with the method of preparation assessed with Visual analogue scale (VAS)
Time Frame: assessed by patient after completion of bowel preparation regimen before colonoscopy (3rd day of the study)
VAS scale is horizontal line 100 mm lenght anchored by word description at each end (very good, very bad).The patient mark on the line the point that feel represent the perception of bowel preparation regimen.
assessed by patient after completion of bowel preparation regimen before colonoscopy (3rd day of the study)

Collaborators and Investigators

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

Investigators

  • Study Chair: Piotr Dziechciarz, MD, Medical University of Warsaw
  • Principal Investigator: Jaroslaw Kierkus, MD, Child Health Center

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

November 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

January 16, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (Estimate)

February 10, 2012

Study Record Updates

Last Update Posted (Estimate)

February 10, 2012

Last Update Submitted That Met QC Criteria

February 9, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • 1/2012

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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