We aim to test the hypothesis that EndoCuff improves totaal number of adenomas detected and ADR compared with regular colonoscopy. In other words, we'll study if the Endocuff colonoscopy detects more polyps.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Mean number of adenomas per patient
Adenoma detection rate (percentage of colonoscopies where at least one adenoma
is found)
Secondary outcome
* Polyp detection rate & number of polyps per patient
* Flat adenoma detection rate
* Polyp retrieval rate
* Cecal intubation rate and cecal intubation time
* Discomfort during the procedure using the Gloucester Comfort scale
* Subjective difficulty of the procedure as assessed by the endoscopist
* Complication rate
Background summary
Colonoscopy is the current reference standard for detection of colorectal
cancer (CRC) and its precursor lesions, adenomas. Several tandem studies have
reported a substantial adenoma miss rate of 20-26%, and approximately 2-12% for
polyps larger than 10mm. Recently a landmark paper was published, that
demonstrated that patients that underwent a screening colonoscopy performed by
an endoscopist with an adenoma detection rate (ADR) of greater than 20% had a
significantly lower chance of developing an interval carcinoma than when scoped
by an endoscopist with an ADR lower than 20%. However, an ADR of 20% is not
always accomplished.
ADR has an inherent limitation as it does not measure the total number of
adenomas detected. Within the British NHS Bowel Cancer Screening program
(BCPS), the mean number of adenomas per procedure (MAP, total number of
adenomas detected divided by the number of procedures) was assessed, besides
the ADR. In the BCPS, MAP was 0.91 in FOBT-positives, whereas in symptomatic
populations MAP is around 0.7.
There are several reasons for missing colonic lesions, including the anatomical
location of polyps on the proximal side of the folds. One of the inventions
aimed at visualizing the proximal surface of the mucosal folds in an effort to
reduce polyp miss rates is a transparent plastic cap that is placed at the tip
of the endoscope. The results of studies comparing cap-assisted colonoscopy
with conventional colonoscopy are however variable. Our study group compared
conventional colonoscopy and cap-assisted colonoscopy in a large randomized
study in an average-risk population and demonstrated no statistical difference
in the ADR between both groups, nor in MAP. We hypothesized that maneuvering
the colonoscope with the cap to each fold, takes a lot of effort for the
colonoscopist. In a large study (approximating daily practice) this may not be
done consequently.
If a cap would be able to straighten colonic folds without blurring the
endoscopic view this could possibly increase detection of polyps on the
proximal side of folds and increase the total number of adenomas detected.
Recently, a cap was developed which aims to do so, the EndoCuff. This special
cap has two circular rows of plastic hairs that, when pulling the scope back,
should distend the folds, prevent slippages of the mucosa and improve tip
control. Besides this potential advantage, EndoCuff could possibly also
facilitate cecal intubation by facilitating straightening of the endoscope
during intubation and prevention of looping. Clinical studies using EndoCuff
have not been performed yet.
Study objective
We aim to test the hypothesis that EndoCuff improves totaal number of adenomas
detected and ADR compared with regular colonoscopy. In other words, we'll study
if the Endocuff colonoscopy detects more polyps.
Study design
Multicenter, open randomized, controlled trial
Study burden and risks
Not applicable
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
*Aged 45 years and older
*Scheduled for colonoscopy for on of the following indications: polyp surveillance, changed bowel habits and/or bloody stools or bowel complaints, FOBT+ screening, positive family history for CRC, abdominal pain
*Signed written informed consent
*ASA class I, II or III
Exclusion criteria
*Polyposis syndromes
*Inflammatory bowel disease (active disease or surveillance)
*Previous partial colonic resection
*Known conditions that require the use of a paediatric colonoscope (severe diverticulosis or abdominal surgery in the medical history)
*Colonoscopy after polyp detection with CT-colonography
*Known colonic stricture
*Any acute indication for colonoscopy
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 | NL42327.018.13 |