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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
  Purpose

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.


Condition Intervention
Split-dose Bowel Preparation
Polyethylene Glycol Solution
Risk Factors Inadequate Preparation
 Other: individual preparation for colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colonoscopy
U.S. FDA Resources

Further study details as provided by Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 266
Study Start Date: August 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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: Individual preparation for colonoscopy 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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476735

Locations
Poland
Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology Recruiting
Warsaw, Poland, 02-781
Contact: Dorota Wretowska, MD     +48501140800     wretowska@tlen.pl    
Contact: Jaroslaw Regula, PhD     +48225463044     jregula@coi.waw.pl    
Sponsors and Collaborators
Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
Investigators
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
  More Information

No publications provided

Responsible Party: Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology
ClinicalTrials.gov Identifier: NCT01476735     History of Changes
Other Study ID Numbers: Individual bowel preparation
Study First Received: November 17, 2011
Last Updated: November 21, 2011
Health Authority: Poland: Ethics Committee

ClinicalTrials.gov processed this record on May 19, 2013