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Retrospective Study on Epidemiology of Colorectal Lesions

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ClinicalTrials.gov Identifier: NCT03035136
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Leonardo Zorron Cheng Tao Pu, Lyell McEwin Hospital

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

Condition or disease
ColoRectal Cancer Colonic Polyp Colonic Neoplasms

Detailed Description:
Colonoscopy reports will be manually searched by the investigator to evaluate epidemiology on colorectal lesions.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2658 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Retrospective Study on Epidemiology of Colorectal Lesions
Actual Study Start Date : January 15, 2017
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : March 5, 2018

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All colonoscopies performed in Lyell McEwin Hospital between 2010 and 2016.
Criteria

Inclusion Criteria:

  • Colonoscopies performed in Lyell McEwin Hospital between 2010-2016

Exclusion Criteria:

  • Sigmoidoscopies

Additional Information:

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Responsible Party: Leonardo Zorron Cheng Tao Pu, Principal Investigator, Lyell McEwin Hospital
ClinicalTrials.gov Identifier: NCT03035136     History of Changes
Other Study ID Numbers: SSA/17/NALHN/3
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Leonardo Zorron Cheng Tao Pu, Lyell McEwin Hospital:
polyps

Additional relevant MeSH terms:
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Colorectal Neoplasms
Colonic Polyps
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical