Telemark Polyp Study, a Trial on Colonoscopy Screening (TPS)

Telemark Polyp Study, a Randomized 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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Procedure: Flexible Sigmoidoscopy Screening arm

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 Type: Interventional
• Enrollment (Actual): 1433
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway
    • Cancer Registry of Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion criteria:

- Colorectal cancer diagnosed before study entry

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Flexible Sigmoidoscopy Screening arm; Intervention by flexible sigmoidoscopy screening	Procedure: Flexible Sigmoidoscopy Screening arm; sigmoidoscopy screening; Other Names: polypectomy
No Intervention: Control arm; No intervention (no screening)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Colorectal cancer mortality	at least 15 years of follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
All cause mortality	at least 15 years of follow-up
colorectal cancer incidence	at least 15 years of follow-up

Collaborators and Investigators

• Sponsor: Norwegian Department of Health and Social Affairs
• Investigators: Study Chair: Geir Hoff, MD, Sykehuset Telemark

Study record dates

Study Major Dates

• Study Start: March 1, 1983
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: November 13, 2009
• First Submitted That Met QC Criteria: November 13, 2009
• First Posted (Estimate): November 16, 2009

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: TPS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No