NCT03361904

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,027

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

November 28, 2017

Last Update Submit

December 1, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (6)

  • Age

    during colonoscopy

  • Gender

    during colonoscopy

  • Indication for colonoscopy

    during colonoscopy

  • quality of the preparation

    during colonoscopy

  • Caecal intubation

    during colonoscopy

  • +1 more secondary outcomes

Interventions

ColonoscopyPROCEDURE

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).

Eligibility Criteria

Age15 Years - 99 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

During the study period, 6335 colorectal endoscopic procedures were realized in the endoscopy unit. We excluded 278 sigmoidoscopies and 30 interventional procedures for stent insertion or stenosis dilation. Only diagnostic colonoscopies were recorded, performed in 3308 women (54.9%) and 2719 men (45.1%) with a median age of 57 (range, 15-96: IQR 18).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic PolypsColonic Neoplasms

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • David Karsenti, MD

    Pole Digestif Paris-Bercy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
7 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 5, 2017

Study Start

January 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

December 5, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share