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Telemark Polyp Study, a Trial on Colonoscopy Screening

NCT01014039 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1433

Last updated 2017-09-14

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Flexible Sigmoidoscopy Screening arm

sigmoidoscopy screening

Sponsors & Collaborators

  • Norwegian Department of Health and Social Affairs

    lead OTHER_GOV

Principal Investigators

  • Geir Hoff, MD · Sykehuset Telemark

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1983-03-31
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • Norway

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01014039 on ClinicalTrials.gov