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

This study has been completed.
Sponsor:
Collaborator:
Institute of Child Health
Information provided by (Responsible Party):
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01531140
First received: January 16, 2012
Last updated: February 9, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention Phase
Colonoscopy Preparation
Drug: polyethylene glycol +Bisacodyl
Drug: Polyethylene glycol
Drug: Sennosides
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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

  • 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 ] [ Designated as safety issue: No ]

    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

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]

    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

  • 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) ] [ Designated as safety issue: No ]
    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.


Enrollment: 240
Study Start Date: November 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Polyethylene glycol
Polyethylene glycol p.o.(Fortrans):60 ml/kg for 2 days
Drug: Polyethylene glycol
Polyethylene glycol p.o.: 60 ml/kg/days
Other Name: Polyethylene glycol: Fortrans
Experimental: PEG + Bisacodyl
Polyethylene glycol p.o.(Fortrans): 30 ml/kg for 2 days + Bisacodyl p.o.: 10-15 mg/day
Drug: polyethylene glycol +Bisacodyl
Polyethylene glycol (Fortrans) p.o. 30 ml/kg/2days + Bisacodyl p.o.10-15 mg/day for 2 days
Other Name: Polyethylene glycol: Fortrans
Experimental: Sennosides
Sennosides: 1tbl/8kg/day for 2 days (1 tbl=8,6 mg sennosides B)
Drug: Sennosides
Sennosides 1tbl/8kg for 2 days
Other Name: Sennosides: Xenna

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.

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531140

Locations
Poland
Child Health Center
Warsaw, Poland, 04-730
Warsaw Medical University
Warsaw, Poland, 01-184
Sponsors and Collaborators
Medical University of Warsaw
Institute of Child Health
Investigators
Study Chair: Piotr Dziechciarz, MD Medical University of Warsaw
Principal Investigator: Jaroslaw Kierkus, MD Child Health Center
  More Information

No publications provided

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01531140     History of Changes
Other Study ID Numbers: 1/2012
Study First Received: January 16, 2012
Last Updated: February 9, 2012
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Medical University of Warsaw:
colonoscopy cleansing
PEG
sennosides
children

Additional relevant MeSH terms:
Bisacodyl
Senna Extract
Sennoside A&B
Cathartics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014