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Individual Approach for Bowel Preparation Before Colonoscopy

This study is currently recruiting participants.
Verified November 2011 by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Sponsor:
Information provided by (Responsible Party):
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier:
NCT01476735
First received: November 17, 2011
Last updated: November 21, 2011
Last verified: November 2011
History of Changes

November 17, 2011
November 21, 2011
August 2011
December 2011   (final data collection date for primary outcome measure)
the index of preparation quality for the whole colon [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
the percentage of patients with adequate bowel preparation; adequate preparation is defined as excellent, good and fair, inadequate is defined as poor or unprepared colon according to the Ottawa bowel preparation scale
Same as current
Complete list of historical versions of study NCT01476735 on ClinicalTrials.gov Archive Site
compliance safety [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
number of patients with completion of preparation number of patients with side effects of preparation in each group
Same as current
Not Provided
Not Provided
 
Individual Approach for Bowel Preparation Before Colonoscopy
A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy

This is a prospective, randomized, single-blind study designed to evaluate the influence of individual approach on bowel preparation quality for colonoscopy. The investigators compare split-dose polyethylene glycol solution (PEG, Fortrans, Beaufour Ipsen) to modified split-dose PEG regarding predictors of inadequate preparation for colonoscopy.

Up to 22% of patients are not good prepared for colonoscopy and it is caused of aborted procedures and increased costs. There are identified predictors of inadequate bowel preparation before colonoscopy, but we still don't know if an individual approach improve the quality of preparation.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Split-dose Bowel Preparation
  • Polyethylene Glycol Solution
  • Risk Factors Inadequate Preparation
Other: individual preparation for colonoscopy
The volume of polyethylene glycol solution depends on risk factors presented in each patient. Time of administration of second dose will be confirmed according to the time of colonoscopy. In case of constipation an enema before colonoscopy will be administered. All patients will give educational booklet of preparation before colonoscopy
  • Active Comparator: split-dose polyethylene glycol solution
    first dose (1,5 l) of polyethylene glycol solution taken at 6-7.00 in the evening before colonoscopy, second dose (1,5 l) taken at 5.30-6.00 in the morning of a day of colonoscopy; additional bisacodyl taken at 12.00 at the day before colonoscopy
    Intervention: Other: individual preparation for colonoscopy
  • Active Comparator: Individual preparation for colonoscopy
    Intervention: Other: individual preparation for colonoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
266
March 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • men and women more than 18 years of age undergoing colonoscopy for routine clinical indications
  • provided written informed consent

Exclusion Criteria:

  • lack of written informed consent or inability to provide informed consent or refusal to consent to the study
  • pregnancy and breast feeding
  • known allergy to PEG or bisakodyl
  • presence of serious conditions such as severe cadiac, renal or metabolic diseases, major psychiatric illness or end-stage cancer disease requiring taking narcotic drugs
  • colonoscopy performed under conscious sedation
Both
18 Years and older
No
Not Provided
Poland
 
NCT01476735
Individual bowel preparation
Yes
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Not Provided
Study Director: Jaroslaw Regula, MD, PhD Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland
Study Chair: Michal F. Kaminski, MD Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland
Principal Investigator: Dorota Wretowska, MD Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology, Warsaw, Poland
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP