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

NCT02712073 | Unknown

• 1 other identifier: DRCI V11 01/01/2015
• Study Type: observational
• Target: 1,260
• Locations: 1 country
• Sites: 4

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.

Conditions

Colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• acceptability of questionnaire

  end of study

• Adenoma detection

  within 6 month

Study Arms (1)

patients undergoing colonoscopy

Other: Questionnaire

Interventions

Questionnaire OTHER

Self administered questionnaire to evaluate the preparation quality of colonoscopy

patients undergoing colonoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen in precolonoscopy consultation

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (4)

Angers UH

Angers, France

RECRUITING

Cholet hospital

Cholet, France

NOT YET RECRUITING

La Roche sur Yon hospital

La Roche-sur-Yon, France

NOT YET RECRUITING

Nantes UH

Nantes, France

NOT YET RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Elodie Cesbron-Métivier, MD

CONTACT

+33241356054; ElMetivier@chu-angers.fr

Nathanaëlle Cornet

CONTACT

+33241356054; nathanaelle.cornet@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2016
• First Posted: March 17, 2016
• Study Start: May 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 13, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)