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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00173277
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
  Purpose

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.


Condition
Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Retrospective/Prospective
Official Title: Screening for CRC Using a Mixed Strategy of Sigmoidoscopy and Colonoscopy in Average-Risk Population According to Age

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 2500
Study Start Date: June 2003
Estimated Study Completion Date: July 2004
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00173277


Contacts
Contact: Jyh-ming Liou, MD 886-2-23123456 ext 5695 dtmed046@ha.mc.ntu.edu.tw

Locations
Taiwan
Departments of Internal Medicine, Medicine National Taiwan University Hospital, Recruiting
Taipei, Taiwan, 100
Contact: Ming-Shiang Wu, MD, PhD    886-2-23123456 ext 5695    stanley@ha.mc.ntu.edu.tw   
Principal Investigator: Jyh-Ming Liou, MD         
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         
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Study Director: Ming-Shiang Wu, MD, PhD Departments of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00173277     History of Changes
Other Study ID Numbers: 9461700610
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
Last Verified: June 2005

Keywords provided by National Taiwan University Hospital:
colorectal cancer screening
colonoscopy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases


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