Viewing Study NCT03361904


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Study NCT ID: NCT03361904
Status: COMPLETED
Last Update Posted: 2017-12-05
First Post: 2017-11-28
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Colonoscopic Adenoma and Advanced Neoplasia Detection Rates According to Age
Sponsor: Société Française d'Endoscopie Digestive
Organization:

Study Overview

Official Title: Adenoma and Advanced Neoplasia Detection Rates Increase From 45 Year of Age: Results of a Monocentric One-year Observational Cohort Study on 6027 Colonoscopies
Status: COMPLETED
Status Verified Date: 2017-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Current recommendations for colonoscopy screening programs usually involve patients older than 50 years of age. However, little is known about polyp or adenoma detection rates under 50. We compared these detection rates according to age in a large series of patients in common practice.

Methods: All colonoscopies performed in 2016 in our unit were prospectively recorded. We determined adenoma detection rate (ADR), polyp detection rate (PDR), mean number of polyps (MNP), and advanced neoplasia detection rate (ANDR).
Detailed Description: Patients All consecutive patients who were scheduled for colonoscopy were included. Exclusion criteria were: patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).

Data collection The following data have been prospectively collected: age, gender, indication for colonoscopy, preparation procedure and quality of the preparation (assessed by the Boston Bowel Preparation Scale; BBPS) \[19-20\], caecal intubation (yes/no), withdrawal time, number and size of polyps and polyp histopathology.

All clinical data were collected during the procedure by a nurse and an endoscopist on a dedicated software. The database was then supplemented by the Clinical Research Associate for histopathological data.

We determined adenoma detection rate (ADR; percentage of colonoscopies with at least one adenoma), polyp detection rate (PDR: percentage of colonoscopies with at least one polyp), mean number of polyps per colonoscopy (MNP), large polyp detection rate (LPDR; percentage of colonoscopies with at least one polyp of 1 cm or more) and advanced neoplasia detection rate (ANDR: percentage of colonoscopies with at least one advanced neoplastic lesion as defined below).

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: