Telemark Polyp Study, a Trial on Colonoscopy Screening

NCT ID: NCT01014039

Last Updated: 2017-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1433 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1983-03-31
• Study Completion Date: 2017-01-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Flexible Sigmoidoscopy Screening arm

Intervention by flexible sigmoidoscopy screening

Group Type: ACTIVE_COMPARATOR

Flexible Sigmoidoscopy Screening arm

Intervention Type: PROCEDURE

sigmoidoscopy screening

Control arm

No intervention (no screening)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Flexible Sigmoidoscopy Screening arm

sigmoidoscopy screening

Intervention Type: PROCEDURE

Other Intervention Names

polypectomy

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Colorectal cancer diagnosed before study entry

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Norwegian Department of Health and Social Affairs

OTHER_GOV

Sponsor Role: lead

Responsible Party

Geir Hoff

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geir Hoff, MD

Role: STUDY_CHAIR

Sykehuset Telemark

Locations

Cancer Registry of Norway

Oslo, , Norway

Countries

Norway

Other Identifiers

TPS

Identifier Type: -

Identifier Source: org_study_id