Assessment of the adenoma detection rate at colonoscopy using :A: Standard colonoscope B: High Definition colonoscope C: High Definition colonoscope with surface enhancementD: High Definition colonoscope with surface enhancement and Colon Mode
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
- Gastrointestinal neoplasms benign
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the adenoma detection rate in all four groups.
Other end-points are: total number of polyps per patient, total number of flat
lesions and time of procedure (withdrawal time). Patients are stratified to the
treatment center.
Secondary outcome
Amount of small and flat lesions
Missed lesions (assessed by questionaire after 60 months)
Background summary
Adenomateous polyps are precursors for colorectal cancer. Colonoscopy is
considered to be the golden standard for the detection of colonic neoplasia.
However, there is a significant number of missed lesions, as assessed by
back-to-back colonoscopy [1-2]. This mis-rate can be attributed to lack of
technique (short withdrawal time, insufficient bowel preparation) or due to
technological causes like the quality of endoscopes to visualise small lesions
and the possibility to look behind folds. Several technological innovations in
both colonoscope design, performances and image processing are tested to
improve colon visualisation and to lower the number of missed lesions. Studies
regarding the effect on adenoma detection rate (ADR) by use of high definition
(HD) endoscopes compared to standard colonoscopes are conflicting. This might
be the result of different expertise of physicians, types of endoscopes and
software applications. The ADR is the most frequently used primary outcome
parameter with respect of screening of colorectal neoplasia and as indicator of
quality assessment.
Recently, Pentax developed a digital mucosal enhancement function, called
I-scan. This function is compatible with their HD colonoscopes. These
endoscopes have the highest resolution available in flexible endoscopy
nowadays. Several function modes are available for the enhancement of vessel
structures and pit pattern. The mode that enhances the mucosal vessel
architecture, thereby improving of detection of small mucosal lesions is called
Surface Enhancement. Digital image processing with emphasis on certain
wavelengths of white light like the Colon Mode will probably add some
additional mucosal and vascular details. The present study is designed to
assess the effect of HD colonoscopy alone or combined with different I-scan
functions compared to standard colonoscopy with respect to adenoma detection
rate.
Study objective
Assessment of the adenoma detection rate at colonoscopy using :
A: Standard colonoscope
B: High Definition colonoscope
C: High Definition colonoscope with surface enhancement
D: High Definition colonoscope with surface enhancement and Colon Mode
Study design
prospective randomized multicenter study
Intervention
colonoscopy
Study burden and risks
Risks are associated with colonoscopy in itself, but not with the type of
endoscope or use of different I-scan functions. Differences in risks between
study groups is unlikely. Serious risks are rare in colonoscopy and are
especially related to interventions during endoscopy (ie polypectomy). Risks of
diagnostic colonoscopy are significant bleeding in 0.005% and perforation in
0.01% of subjects. There is no increased risk for subjects participating in the
study
postbus 5800
6202 AZ Maastricht
NL
postbus 5800
6202 AZ Maastricht
NL
Listed location countries
Age
Inclusion criteria
patients (> 40 years old) undergoing diagnostic colonoscopy because of one of the following five indications: 1: abdominal complaints, 2: chronic diarrhea, 3: (family) history of adenomateous polyps or CRC, 4: rectal bloodloss and 5: iron deficiency anemia.
Exclusion criteria
Previous extended colon surgery, inflammatory bowel disease (IBD), Hereditary polyposis syndromes, known gastrointestinal neoplasia before endoscopy (based on recent endoscopy or other imaging like CT)
Patients <40 years
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28389.068.09 |