Colonoscopic Adenoma and Advanced Neoplasia Detection Rates According to Age

Colon Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03361904
• Other study ID #: 2016-ADR according to age
• Status: Completed
• Phase: N/A
• First received: November 28, 2017
• Last updated: December 1, 2017
• Start date: January 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: December 2017
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6027
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Gender: All
• Age group: 15 Years to 99 Years

Eligibility

Inclusion Criteria:

• All consecutive patients who were scheduled for colonoscopy were included.

Exclusion Criteria:

• patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).

Related Conditions & MeSH terms

• Adenoma
• Age
• Colon Adenoma
• Colon Cancer
• Colonic Polyp
• Colonic Polyps
• Colonoscopy

Intervention

Procedure:
• Colonoscopy
Total colonoscopy : 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate according to age	ADR <30yo, in 30-34 yo, in 35-39yo, in 40-44yo, in 45-49yo, in 50-54yo, in 55-59yo, in 60-64yo, in 65-69 yo, in 70-74yo, in 75-79yo and >79yo intervals	during colonoscopy
Primary	Advanced Neoplasia Detection rate according to age	ANDR <30yo, in 30-34 yo, in 35-39yo, in 40-44yo, in 45-49yo, in 50-54yo, in 55-59yo, in 60-64yo, in 65-69 yo, in 70-74yo, in 75-79yo and >79yo intervals	during colonoscopy
Secondary	Age	years old	during colonoscopy
Secondary	Gender	Male or Female	during colonoscopy
Secondary	Indication for colonoscopy	pain / screening/ familial or personal history of polyp or cancer	during colonoscopy
Secondary	quality of the preparation	Boston Bowel Preparation Scale Segment Score Description 0: unprepared colon segment with mucosa not senn due to solid stool that cannot be cleared; Portion of mucosa of the colon segment seen, but other areas of the colon segment are not well seen due to staining, residual stool, and/or opaque liquid; minor amount of residual staining, small fragments of stool, and/or opaque liquid, but mucosa of colon segments is seen well; entire mucosa of colon segment seen well, with no residual staining, small fragments of stool or opaque liquid; Total score is a summation of scores from three segments of the colon Score is from 0 to 9	during colonoscopy
Secondary	Caecal intubation	Y/N	during colonoscopy
Secondary	Withdrawal time	in seconds	during colonoscopy