Clinical trial NCT00173277: Screening for CRC Using a Mixed Strategy of Sigmoidoscopy and Colonoscopy in Average-Risk Population According to Age
Official title: Screening for CRC Using a Mixed Strategy of Sigmoidoscopy and Colonoscopy in Average-Risk Population According to Age
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: colorectal cancer screening
colonoscopy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 2500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Departments of Internal Medicine, Medicine National Taiwan University Hospital,
Study officials:
affiliation: Departments of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan
name: Ming-Shiang Wu, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Lieberman DA, Weiss DG, Bond JH, Ahnen DJ, Garewal H, Chejfec G. Use of colonoscopy to screen asymptomatic adults for colorectal cancer. Veterans Affairs Cooperative Study Group 380. N Engl J Med. 2000 Jul 20;343(3):162-8. doi: 10.1056/NEJM200007203430301.