Predictive Score of the Bowel Preparation Quality Based on a Self-administered Questionnaire (PREPA-CO)

April 12, 2016 updated by: University Hospital, Angers
In France, nearly 1.3 million colonoscopies are performed each year. Colonoscopy is the gold standard in France for colorectal cancer screening in populations at risk. However, it has a number of limitations. The quality of the bowel preparation is a critical step for the successful completion of this examination. The occurrence of interval cancers raises the problem of missed lesions. A literature review showed that there were differences between the endoscopy units on quality standards for bowel preparation. The rate of unprepared colonoscopy is estimated between 20 to 40% . In a recent cohort study, 28% of 2516 colonoscopies had a score of Boston of less than or equal to 6. These colonoscopies generate substantial additional costs to redo colonoscopies, estimated at 35 million euros in 2008. The establishment a predictive score for quality of bowel preparation based on a self-administered questionnaire completed by patients during the pre-colonoscopy consultation, would help identify patients at risk of poor preparation in order to optimize the prescribed preparation in this consultation.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
      • Cholet, France
        • Not yet recruiting
        • Cholet Hospital
        • Contact:
          • Mehdi Kaassis
      • La Roche sur Yon, France
        • Not yet recruiting
        • La Roche Sur Yon Hospital
        • Contact:
          • Morgane AMIL
      • Nantes, France
        • Not yet recruiting
        • Nantes UH
        • Contact:
          • Emmanuel Coron, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients seen in precolonoscopy consultation

Description

Inclusion Criteria:

  • Men or woman > 18 years old
  • Patient agreeing to participate in the study
  • Prescription of a bowel preparation respecting the marketing authorization.

Exclusion Criteria:

  • Major patient under guardianship, or protected person,
  • Pregnant woman,
  • Patient who doesn't understand French or can't read
  • People not affiliated with a social security scheme or of such a scheme

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients undergoing colonoscopy
Other: Questionnaire
Self administered questionnaire to evaluate the preparation quality of colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Score performance
Time Frame: within 6 month
score performance to predict a poor bowel preparation (defined by a score of Boston inferior or equal to 7 and / or a segment equal to 1)
within 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acceptability of questionnaire
Time Frame: end of study
Acceptability of the questionnaire evaluated by the rate of return of the questionnaires and the rate of well completed questionnaires
end of study
Adenoma detection
Time Frame: within 6 month
adenoma detection rate compared to Boston score
within 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

March 14, 2016

First Submitted That Met QC Criteria

March 14, 2016

First Posted (Estimate)

March 17, 2016

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DRCI V11 01/01/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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