NCT03035136

Brief Summary

Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,658

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

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 15, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2018

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2018

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

1.1 years

First QC Date

January 25, 2017

Last Update Submit

March 5, 2018

Conditions

ColoRectal CancerColonic PolypColonic Neoplasms

Keywords

polyps

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    Percentage of screening patients with at least one adenomatous lesion found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure

    Day 1

Secondary Outcomes (2)

  • SSA/P detection rate

    Day 1

  • Polyp detection rate

    Day 1

Study Arms (2)

Patients with colorectal lesions

Patients with a full colonoscopy that showed either a cancer or a polyp.

Patients without colorectal lesions

Patients with a full colonoscopy that showed no polyps.

Eligibility Criteria

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

All colonoscopies performed in Lyell McEwin Hospital between 2010 and 2016.

You may qualify if:

  • Colonoscopies performed in Lyell McEwin Hospital between 2010-2016

You may not qualify if:

  • Sigmoidoscopies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsColonic PolypsColonic NeoplasmsPolyps

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesIntestinal PolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 27, 2017

Study Start

January 15, 2017

Primary Completion

February 15, 2018

Study Completion

March 5, 2018

Last Updated

March 7, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share