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Retrospective Study on Epidemiology of Colorectal Lesions

Sponsor
Lyell McEwin Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03035136
Collaborator
(none)
2,658
Enrollment
13.6
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    2658 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Retrospective Study on Epidemiology of Colorectal Lesions
    Actual Study Start Date :
    Jan 15, 2017
    Actual Primary Completion Date :
    Feb 15, 2018
    Actual Study Completion Date :
    Mar 5, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Adenoma detection rate [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Colonoscopies performed in Lyell McEwin Hospital between 2010-2016
    Exclusion Criteria:
    • Sigmoidoscopies

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Lyell McEwin Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Leonardo Zorron Cheng Tao Pu, Principal Investigator, Lyell McEwin Hospital
    ClinicalTrials.gov Identifier:
    NCT03035136
    Other Study ID Numbers:
    • SSA/17/NALHN/3
    First Posted:
    Jan 27, 2017
    Last Update Posted:
    Mar 7, 2018
    Last Verified:
    Mar 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Principal Investigator, Lyell McEwin Hospital
    polyps
    Additional relevant MeSH terms:
    Colonic Neoplasms
    Colonic Polyps

    Study Results

    No Results Posted as of Mar 7, 2018