We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Bowel Prep Acceptance in Clinical Practice

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02287051
Recruitment Status : Completed
First Posted : November 10, 2014
Last Update Posted : November 10, 2014
Information provided by (Responsible Party):
Arnaldo Amato, Valduce Hospital

Brief Summary:
Bowel preparation for colonoscopy is crucial, since the diagnostic accuracy of the procedure depends on an adequate visualization of the mucosa of the colon.There is strong evidence that the quality of bowel preparation is inversely correlated with the interval between the end of the assumption of the purgative and the start of colonoscopy (shorter intervals are associated with higher levels of preparation).Recent studies have shown that split dose prep significantly improves the quality of bowel cleansing. In light of these data, both the American College of Gastroenterology (ACG) and the European Society of Gastrointestinal Endoscopy (ESGE) recommend now split dose prep in order to improve the quality of bowel cleansing. Despite these recommendations, the uptake of schemes in divided doses appears clearly underused in actual clinical practice. In particular, in Italy only a few centers routinely adopt the regime split as their first choice for the preparation for colonoscopy.The reasons why the "split dose" is under-utilized in clinical practice are not entirely clear, but probably in part reflecting gastroenterologists' concerns about potential elements that theoretically could make it less acceptable to the patient (get up early in the morning, potential problems during the journey from home to the hospital) The hypothesis of the study is that many patients would still be willing to accept these potential drawbacks if they were adequately informed about the positive impact of the scheme in divided doses on the effectiveness of bowel preparation, which results in higher reliability of the examination, shorter duration of the procedure, and less risk of rescheduling the exam in the near future

Condition or disease
Colonoscopy: Bowel Preparation

Layout table for study information
Study Type : Observational
Actual Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Acceptance and Compliance of Split-dose Bowel Preparation for Colonoscopy in Clinical Practice
Study Start Date : March 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

colonoscopy population

Primary Outcome Measures :
  1. acceptance [ Time Frame: 3 month ]
    structured questionnaire on acceptability and problems related to the modality of the preparation

  2. compliance [ Time Frame: 3 month ]
    structured questionnaire on completeness and difficulties related to the modality of the preparation

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
population undergoing colonoscopy

Inclusion Criteria:

  • adult patientes undergoing colonscopy

Exclusion Criteria:

  • afternoon colonoscopy
  • partial colonoscopy
  • pregnancy
  • incapacity to give informed consent
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Arnaldo Amato, MD, Valduce Hospital
ClinicalTrials.gov Identifier: NCT02287051    
Other Study ID Numbers: 7/14
First Posted: November 10, 2014    Key Record Dates
Last Update Posted: November 10, 2014
Last Verified: November 2014