Telemark Polyp Study, a Trial on Colonoscopy Screening (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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening|
- Colorectal cancer mortality [ Time Frame: at least 15 years of follow-up ]
- All cause mortality [ Time Frame: at least 15 years of follow-up ]
- colorectal cancer incidence [ Time Frame: at least 15 years of follow-up ]
|Study Start Date:||March 1983|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2020 (Final data collection date for primary outcome measure)|
Active Comparator: Flexible Sigmoidoscopy Screening arm
Intervention by flexible sigmoidoscopy screening
Procedure: Flexible Sigmoidoscopy Screening arm
Other Name: polypectomy
No Intervention: Control arm
No intervention (no screening)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014039
|Cancer Registry of Norway|
|Study Chair:||Geir Hoff, MD||Sykehuset Telemark|