Screening for CRC Using a Mixed Strategy of Sigmoidoscopy and Colonoscopy in Average-Risk Population According to Age

September 12, 2005 updated by: National Taiwan University Hospital

BACKGROUND: Primary screening with sigmoidoscopy would miss a substantial proportion of advanced proximal neoplasia (APN), but screening with universal colonoscopy is costly. The aim of this study is to assess the efficacy of mixed strategy which uses sigmoidoscopy for younger patients and colonoscopy for older patients.

MATERIALS and METHODS: We analyzed an established database containing consecutive average-risk adults aged 50 or older who underwent screening colonoscopy as part of health check-up. We assessed the efficacy of mixed screening strategy using colonoscopy for persons aged at and above a certain cut-off age and sigmoidoscopy for persons aged below that age. Those who underwent sigmoidoscopy initially would be referred for subsequent colonoscopy if distal sentinel lesion was detected.

Study Overview

Status

Unknown

Conditions

Detailed Description

Because the prevalence of proximal colon cancer and APN was higher in older patients15, a greater proportion of advanced colonic neoplasia or cancer would be missed if colonoscopy was not performed for older patients. So if we develop a mixed strategy to offer sigmoidoscopy for younger patients and reserve colonoscopy for older patients, we might be able to detect more APN with fewer colonoscopic procedures. We aimed to determine an optimal cut-off age and choose an appropriate distal sentinel lesion for subsequent colonoscopy.

Study Type

Observational

Enrollment

2500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Taipei, Taiwan, 100
        • Recruiting
        • Departments of Internal Medicine, Medicine National Taiwan University Hospital,
        • Contact:
        • Principal Investigator:
          • Shi-Pei Huang, MD,PhD
        • Sub-Investigator:
          • Han-Mo Chiu, MD
        • Sub-Investigator:
          • Hsiu-Po Wang, MD
        • Principal Investigator:
          • aw-Town Lin, MD,PhD

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Only asymptomatic ethnic Chinese subjects aged 50 years or older who underwent total colonoscopy were included in this study

Exclusion Criteria:

  • Persons with symptoms indicative of colorectal cancer, such as hematochezia, body weight loss, development of persistent abdominal pain or rectal pain, and a change in bowel habit, were excluded from this study. Other exclusion criteria were: (1) past history of CRC, colon polyps, or inflammatory bowel disease; (2) a history of screening tests, including FOBT, sigmoidoscopy, colonoscopy, or barium studies within 5 years; (3) any first degree relative(s) with colon cancer; (4) criteria for hereditary nonpolyposis colorectal cancer, familial adenomatous polyposis, or other polyposis syndrome; (5) obvious anemia with hemoglobin level less than 10g/dl; (6) incomplete examination of entire colon, including poor colon preparation and failure to reach cecum.

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Ming-Shiang Wu, MD, PhD, Departments of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan

Publications and helpful links

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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

June 1, 2003

Study Completion

July 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

September 15, 2005

Last Update Submitted That Met QC Criteria

September 12, 2005

Last Verified

June 1, 2005

More Information

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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