ISRCTN - ISRCTN59303311: Capsule colonoscopy option increases uptake of colorectal cancer screening

Plain English Summary

Background and study aims:
Colorectal cancer screening is used to detect cancer at an early stage, before symptoms start to appear. It is done because treating the disease is more successful if its caught at an early stage. Endoscopy is an effective method of exploring the bowel for signs of cancer. A thin, flexible tube with a tiny camera attached is placed into the bowel. The medical team is then able to see the inside of the bowel though images sent to a television screen. Despite its success, many people who would otherwise benefit from the procedure (i.e. people over the age of 55) are reluctant to take part due, in part, to it being thought of as unpleasant. Capsule endoscopy is a new method which is painless and involves swallowing a small pill-like video camera which travels through the bowel and takes images. It is thought that capsule endoscopy might encourage more people to undergo colorectal cancer screening. This study aims to explore whether inviting people to undertake endoscopic screening for colorectal cancer and offering the new capsule endoscopy will persuade more people to go for screening compared to those offered conventional endoscopy.

Who can participate?
People over the age of 55 who are insured with BKK 24 in the area of Rintein/Lower Saxonia (Germany)

What does the study involve?
The participants receive an invitation letter for colorectal cancer screening by either conventional or capsule endoscopy. The participants then respond if they want to undergo the procedure.

What are the possible benefits and risks of participating?
The study per se only measures uptake. The risks of the endoscopic procedures are well known and will be communicated in the informed consent

Where is the study run from?
Rinteln, Lower Saxonia, Germany

When is study starting and how long is it expected to run for?
March 2009 to July 2011

Who is funding the study?
Given Imaging Ltd (Germany)

Who is the main contact?
Prof. Dr. Thomas Rösch
t.roesch@uke.de

Trial website

Contact information

Type

Scientific

Primary contact

Prof Thomas Rösch

ORCID ID

Contact details

Department of Interdisciplinary Endoscopy
University Hospital Hamburg Eppendorf
Martinistr. 52
Hamburg
20246
Germany
t.roesch@uke.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CRCS Uptake study 1

Study information

Scientific title

Capsule colonoscopy option increases uptake of colorectal cancer screening: a prospective regional study in Germany

Acronym

Study hypothesis

Capsule colonoscopy increases uptake as compared to conventional colonoscopy when offered to persons eligible for colorectal cancer screening

Ethics approval

International Medical & Dental Ethics Commission (IMDEC) GmbH Ethical Committee, Freiburg approved on 31st March 2009

Study design

Prospective single arm study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colorectal cancer screening

Intervention

2150 participants receive an invitation letter for colorectal cancer screening by either conventional or capsule endoscopy. The pros and cons of each are briefly described and can be further discussed with four gastroenterologists who are named in the letter. Follow-up is 1-2 weeks after capsule and/or conventional colonoscopy.

The practical part of the study took part in 2009. It took until the end of last year to collect all the data from private practice physicians (time constraints for audits).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Uptake of capsule and conventional endoscopy after invitation (measured whenever patients react to the letters, usually within a few weeks) as compared to spontaneous uptake in the same area in the preceeding years

Secondary outcome measures

1. Adenoma yield in both groups, namely the capsule group including those participants with subsequent colonoscopy, and the group with capsule colonoscopy only
2. Rate of capsule examinations with sufficient bowel preparation (grading was done on a 4-point scale in accordance with previous studies
3. Adverse events and complications in both arms of the study
4. Patient opinion and acceptability according to the questionnaires

Measured during or after (2 weeks) performance of either conventional and/or capsule endoscopy

Overall trial start date

01/03/2009

Overall trial end date

31/07/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Persons over 55 years of age eligible for screening insured with BKK 24 in the area of Rinteln/Lower Saxonia (Germany) are invited by a letter sent out from BKK 24 medical insurance during 2009 to participate in screening using either capsule or conventional colonoscopy.
2. Interested persons are informed by four gastroenterologists and one of the tests will then be performed at screnees choice

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2150

Participant exclusion criteria

1. Symptomatic persons
2. Persons having undergone screening colonoscopy

Recruitment start date

01/03/2009

Recruitment end date

31/07/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Interdisciplinary Endoscopy
Hamburg
20246
Germany

Sponsor information

Organisation

Given Imaging Ltd. (Germany)

Sponsor details

c/o Manfred Gehrtz
Borsteler Chaussee 47
Hamburg
22453
Germany
Manfred.Gehrtz@givenimaging.com