Telemark Polyp Study, a Trial on Colonoscopy Screening

Study Overview
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Brief Summary
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Colonoscopy screening to reduce mortality and incidence of colorectal cancer (CRC) has been implemented in many western countries. The estimated effect is based on case-control and observational studies. There are no randomized trials quantifying the effect of colonoscopy screening on CRC incidence and mortality. The present study investigates the effect of a population-based once-only colonoscopy screening with polypectomy on the incidence of CRC in an average risk population. In 1983, 900 individuals 55 to 64 years of age were randomly drawn from the population registry of Telemark county, Norway. 400 of these were invited to a flexible sigmoidoscopy screening examination, and 400 individuals were not offered any screening. In 1996, the remainder, both cohorts from 1983 were invited to a colonoscopy screening examination. A new age and sex matched control group, not being offered screening, was randomly drawn from the same registry. Both groups are to be followed with regard to CRC incidence, CRC mortality and all-cause mortality through national Norwegian registries.

Detailed Description
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This as a randomized study of once-only colonoscopy screening (n=685) vs/no screening(care as usual)(n=684). Men and women at 63-72 years of age are recruited from the population registry. The intervention group is invited for screening after a bowel cleansing regimen at home. Follow-up is restricted to trace events (colorectal cancer incidence and deaths) through national registries.

Official Title
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Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: Flexible Sigmoidoscopy Screening arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 55 to 64 years old Both male and female Exclusion criteria: - Colorectal cancer diagnosed before study entry

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Flexible Sigmoidoscopy Screening arm<br>Intervention by flexible sigmoidoscopy screening | Procedure: Flexible Sigmoidoscopy Screening arm<br>* sigmoidoscopy screening<br>* Other names: polypectomy;|
| No Intervention: Control arm<br>No intervention (no screening) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colorectal cancer mortality |  | at least 15 years of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause mortality |  | at least 15 years of follow-up | 
| colorectal cancer incidence |  | at least 15 years of follow-up |