Telemark Polyp Study, a Trial on Colonoscopy Screening

Not Applicable

Completed

• Conditions: Colorectal Cancer
• Interventions: Procedure: Flexible Sigmoidoscopy Screening arm

• Registration Number: NCT01014039
• Lead Sponsor: Norwegian Department of Health and Social Affairs

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.

Study Timeline

• Study Start: 1983-03
• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-13
• Last Update Posted: 2017-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1433

Inclusion Criteria

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

Exclusion criteria:

• Colorectal cancer diagnosed before study entry

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexible Sigmoidoscopy Screening arm	Flexible Sigmoidoscopy Screening arm	Intervention by flexible sigmoidoscopy screening

Primary Outcome Measures

Name	Time	Method
Colorectal cancer mortality	at least 15 years of follow-up

Secondary Outcome Measures

Name	Time	Method
All cause mortality	at least 15 years of follow-up
colorectal cancer incidence	at least 15 years of follow-up

Trial Locations

Locations (1)

Cancer Registry of Norway; 🇳🇴 Oslo, Norway