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OpenTrials
Completed

NCT Number: NCT01476735

Individual Approach for Bowel Preparation Before 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.

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Key information

Conditions

Split-dose Bowel Preparation Polyethylene Glycol Solution Risk Factors Inadequate Preparation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maria Sklodowska-Curie Memorial cancer Center, Institute of Oncology

Warsaw, 02-781, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

individual preparation for colonoscopy

Other

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

Primary outcomes

  1. the index of preparation quality for the whole colon

    Time frame: 24 hours

    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 outcomes

  1. compliance safety

    Time frame: 24 hours

    number of patients with completion of preparation number of patients with side effects of preparation in each group

Sponsors and collaborators

Lead sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Other

Registry information

Official study title

A Prospective, Randomized, Single-blind Study Evaluating Individual Approach on Bowel Preparation Quality for Colonoscopy

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Nov 22, 2011
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.