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Telemark Polyp Study, a Trial on Colonoscopy Screening

Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01014039
Acronym
TPS
Enrollment
1433
Registered
2009-11-16
Start date
1983-03-31
Completion date
2017-01-31
Last updated
2017-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

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

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.

Interventions

PROCEDUREFlexible Sigmoidoscopy Screening arm

sigmoidoscopy screening

Sponsors

Norwegian Department of Health and Social Affairs
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 55 to 64 years old * Both male and female

Exclusion criteria

\- Colorectal cancer diagnosed before study entry

Design outcomes

Primary

MeasureTime frame
Colorectal cancer mortalityat least 15 years of follow-up

Secondary

MeasureTime frame
All cause mortalityat least 15 years of follow-up
colorectal cancer incidenceat least 15 years of follow-up

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026