This trial is active, not recruiting.

Condition colorectal cancer
Treatment flexible sigmoidoscopy screening arm
Sponsor Norwegian Department of Health and Social Affairs
Start date March 1983
End date December 2020
Trial size 1600 participants
Trial identifier NCT01014039, TPS


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
(Active Comparator)
Intervention by flexible sigmoidoscopy screening
flexible sigmoidoscopy screening arm polypectomy
sigmoidoscopy screening
(No Intervention)
No intervention (no screening)

Primary Outcomes

Colorectal cancer mortality
time frame: at least 15 years of follow-up

Secondary Outcomes

All cause mortality
time frame: at least 15 years of follow-up
colorectal cancer incidence
time frame: at least 15 years of follow-up

Eligibility Criteria

Male or female participants from 55 years up to 64 years old.

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

Additional Information

Official title Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by Norwegian Department of Health and Social Affairs.