- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03035136
Retrospective Study on Epidemiology of Colorectal Lesions
March 5, 2018 updated by: Leonardo Zorron Cheng Tao Pu, Lyell McEwin Hospital
Retrospective analysis on colonoscopies in the endoscopy unit of the Lyell McEwin Hospital.
Study Overview
Status
Completed
Conditions
Detailed Description
Colonoscopy reports will be manually searched by the investigator to evaluate epidemiology on colorectal lesions.
Study Type
Observational
Enrollment (Actual)
2658
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All colonoscopies performed in Lyell McEwin Hospital between 2010 and 2016.
Description
Inclusion Criteria:
- Colonoscopies performed in Lyell McEwin Hospital between 2010-2016
Exclusion Criteria:
- Sigmoidoscopies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adenoma detection rate
Time Frame: Day 1
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SSA/P detection rate
Time Frame: Day 1
|
Percentage of screening patients with at least one SSA/P found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure
|
Day 1
|
Polyp detection rate
Time Frame: Day 1
|
Percentage of screening patients with at least one polyp found - to be compared between Gastroenterologists and Surgeons and based on scheduling of the procedure
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 15, 2017
Primary Completion (ACTUAL)
February 15, 2018
Study Completion (ACTUAL)
March 5, 2018
Study Registration Dates
First Submitted
January 25, 2017
First Submitted That Met QC Criteria
January 26, 2017
First Posted (ESTIMATE)
January 27, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 7, 2018
Last Update Submitted That Met QC Criteria
March 5, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Pathological Conditions, Anatomical
- Intestinal Neoplasms
- Colorectal Neoplasms
- Polyps
- Intestinal Polyps
- Colonic Polyps
- Colonic Neoplasms
Other Study ID Numbers
- SSA/17/NALHN/3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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