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

Colonoscopy Clinical Trial

— PREPA-CO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02712073
• Other study ID #: DRCI V11 01/01/2015
• Status: Recruiting
• Phase: N/A
• First received: March 14, 2016
• Last updated: April 12, 2016
• Start date: May 2015
• Est. completion date: September 2017

Study information

• Verified date: April 2016
• Source: University Hospital, Angers
• Contact: Elodie Cesbron-Métivier, MD
• Phone: +33241356054
• Email: ElMetivier[@]chu-angers.fr
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1260
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Other:
• Questionnaire
Self administered questionnaire to evaluate the preparation quality of colonoscopy

Locations

Country	Name	City	State
France	Angers UH	Angers
France	Cholet hospital	Cholet
France	La Roche sur Yon hospital	La Roche sur Yon
France	Nantes UH	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score performance	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	No
Secondary	acceptability of questionnaire	Acceptability of the questionnaire evaluated by the rate of return of the questionnaires and the rate of well completed questionnaires	end of study	No
Secondary	Adenoma detection	adenoma detection rate compared to Boston score	within 6 month	No