Predictive Score of the Bowel Preparation Quality Based on a Self-administered Questionnaire

NCT ID: NCT02712073

Last Updated: 2016-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colonoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients undergoing colonoscopy

Questionnaire

Intervention Type OTHER

Self administered questionnaire to evaluate the preparation quality of colonoscopy

Interventions

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Questionnaire

Self administered questionnaire to evaluate the preparation quality of colonoscopy

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Angers UH

Angers, , France

Site Status RECRUITING

Cholet hospital

Cholet, , France

Site Status NOT_YET_RECRUITING

La Roche sur Yon hospital

La Roche-sur-Yon, , France

Site Status NOT_YET_RECRUITING

Nantes UH

Nantes, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Elodie Cesbron-Métivier, MD

Role: CONTACT

+33241356054

Nathanaëlle Cornet

Role: CONTACT

+33241356054

Facility Contacts

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Elodie Cesbron-Métivier, MD

Role: primary

+33241356054

Nathanaëlle Cornet

Role: backup

+33241356054

Mehdi Kaassis

Role: primary

Morgane Amil

Role: primary

Emmanuel Coron, MD

Role: primary

Other Identifiers

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DRCI V11 01/01/2015

Identifier Type: -

Identifier Source: org_study_id

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