Comparison of adenoma miss rate and adenoma detection rates between Endocuff Vission-assisted colonoscopy and conventional colonoscopy: a multicenter randomized trial (EXCEED study)

Population screening programs for colorectal cancers (CRC) are increasingly
adapted as a public health initiative with
the primary goal to prevent CRC and CRC related deaths. The ultimate benefit of
CRC screening relies on the
detection and resection of (pre-)malignant colon lesions, and for this
colonoscopy is the preferred modality. Recently,
concerns have been raised about the effectiveness of colonoscopy in the
prevention of CRC after several studies
reported unexpected high incidence rates of interval carcinomas (lC),
especially in the proximal colon.[5-9] Most lCs
are suspected to arise from missed colon lesions during colonoscopy. The
retrograde approach of colonic inspections
may contribute to colon lesions remaining undetected as it limits visualization
of the proximal sides of haustral folds
and flexures. Endocuff Vision is a single-use, disposable medical device
designed to improve the detection of colon
lesions. The 'finger-like' projections of the device provide fold retraction
allowing the visualization of otherwise hidden
anatomical areas. Additionally, Endocuff Vision may improve scope tip stability
and prevent scope slippage.
The present study will be the first study to compare adenoma miss rates (AMR)
and ADR between Endocuff
Vision-assisted colonoscopy (EAC) and conventional colonoscopy (CC) in
non-IFOBT based colonoscopy patients.
Additionally, this study will evaluate whether a proposed increased ADR and
reduced AMR with EAC is indeed due to
the accessory device or merely a consequence of the second colonoscopy
procedure performed.

(1) To compare adenoma miss rates (AMR) between Endocuff Vision-assisted
colonoscopy (EAC) and conventional
colonoscopy (CC)
(2) To compare adenoma detection rates (ADR) between EAC and CC
(3) To assess whether a proposed increased ADR and reduced AMR with EAC is
indeed due to the fold-flattening
device or merely a consequence of the second colonoscopy procedure performed.
(4) To assess the clinical relevance of the polyps missed during the first
colonoscopy procedure.

This multicenter randomized, same-day, back-to-back tandem colonoscopy trial
will include four separate study groups:
group A; CC followed by CC, Group B; CC followed by EAC, Group C; EAC followed
by CC, and group D; EAC
followed by EAC.

Endocuff Vision- assisted colonoscopy

Colonoscopy is a commonly performed procedure and the overall serious adverse
event (SAE) rate is low, around 2.8
per 1000 colonoscopies. The risk of adverse events (AE) for EAC are believed to
be equivalent to CC, including
bleeding and perforation risks. Patients burden will consist of two follow-up
telephone calls to assess patients reported
outcome and adverse events. Additionally, general colonoscopy related risk may
increase in a repeated colonoscopy
trial. A very important benefit for participating subjects relies in a more
thorough investigation of the colon. Repeated
colonoscopy has been shown to result in the detection of more neoplastic colon
lesions, which has been inversely
related to the risk of developing interval carcinomas.