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

• Conditions: Colonoscopy
• Interventions: Other: Questionnaire

• Registration Number: NCT02712073
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-14
• Study First Posted: 2016-03-17
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-12
• Last Update Posted: 2016-04-13
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1260

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients undergoing colonoscopy	Questionnaire	-

Primary Outcome Measures

Name	Time	Method
Score performance	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

Name	Time	Method
acceptability of questionnaire	end of study	Acceptability of the questionnaire evaluated by the rate of return of the questionnaires and the rate of well completed questionnaires
Adenoma detection	within 6 month	adenoma detection rate compared to Boston score

Trial Locations

Locations (4)

Angers UH; 🇫🇷 Angers, France

Cholet hospital; 🇫🇷 Cholet, France

La Roche sur Yon hospital; 🇫🇷 La Roche sur Yon, France

Nantes UH; 🇫🇷 Nantes, France