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

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ClinicalTrials.gov Identifier: NCT02712073
Recruitment Status : Unknown
Verified April 2016 by University Hospital, Angers.
Recruitment status was:  Recruiting
First Posted : March 17, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
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.

Condition or disease Intervention/treatment
Colonoscopy Other: Questionnaire

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Study Type : Observational
Estimated Enrollment : 1260 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Score of the Bowel Preparation Quality Based on a Self-administered Questionnaire
Study Start Date : May 2015
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Adenoma detection [ Time Frame: within 6 month ]
    adenoma detection rate compared to Boston score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients seen in precolonoscopy consultation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712073


Contacts
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Contact: Elodie Cesbron-Métivier, MD +33241356054 ElMetivier@chu-angers.fr
Contact: Nathanaëlle Cornet +33241356054 nathanaelle.cornet@chu-angers.fr

Locations
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France
Angers UH Recruiting
Angers, France
Contact: Elodie Cesbron-Métivier, MD    +33241356054    ElMetivier@chu-angers.fr   
Contact: Nathanaëlle Cornet    +33241356054    nathanaelle.cornet@chu-angers.fr   
Cholet hospital Not yet recruiting
Cholet, France
Contact: Mehdi Kaassis         
La Roche sur Yon hospital Not yet recruiting
La Roche sur Yon, France
Contact: Morgane Amil         
Nantes UH Not yet recruiting
Nantes, France
Contact: Emmanuel Coron, MD         
Sponsors and Collaborators
University Hospital, Angers

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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02712073     History of Changes
Other Study ID Numbers: DRCI V11 01/01/2015
First Posted: March 17, 2016    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No