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Completed

NCT Number: NCT01014039

Telemark Polyp Study, a Trial on Colonoscopy Screening

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

55 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Registry of Norway

Oslo, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Colorectal cancer diagnosed before study entry

Treatment and study plan

Flexible Sigmoidoscopy Screening arm

Procedure

sigmoidoscopy screening

Other names: polypectomy

Primary outcomes

  1. Colorectal cancer mortality

    Time frame: at least 15 years of follow-up

Secondary outcomes

  1. All cause mortality

    Time frame: at least 15 years of follow-up

  2. colorectal cancer incidence

    Time frame: at least 15 years of follow-up

Sponsors and collaborators

Lead sponsor

Norwegian Department of Health and Social Affairs

Other Gov

Registry information

Official study title

Telemark Polyp Study, a Randomized Trial on Colonoscopy Screening

Acronym: TPS

Important dates

Study start
1983
Primary completion
2017
Study completion
2017
First posted
Nov 16, 2009
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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