A new method for bowel cleansing in patients with a history of poor bowel preparation * A multicenter feasibility study with the Pure-Vu

Rationale: It is widely acknowledged that the efficacy and safety of
colonoscopy depends on the quality of the pre-procedural bowel preparation.
Despite its importance, the proportion of colonoscopies with inadequate bowel
preparation still ranges from 6.8-33% across studies. A past history of poor
bowel preparation is the most important risk factor of inadequate bowel
cleansing at the next colonoscopy. (1, 2) Evidence to recommend a specific
bowel cleansing regimen in these patients is currently lacking. (3) Mostly,
patients with previous bowel preparation are advised to drink more oral
purgatives, which is very difficult and unpleasant for patients and therefore
often fails.
The aim of this study is to evaluate if an intra-procedural bowel cleaning
device, the Pure-VuTM system (Tirat Carmel, Israel) can be used to achieve an
adequate level of bowel cleansing in patients with previous poor bowel
preparation.

Objective: The aim of this study is to evaluate if an adequate level of bowel
cleansing can be achieved with the Pure-Vu in patients with previous poor bowel
preparation (Boston Bowel Preparation Scale [BBPS]<6).

We will perform an international multicenter colonoscopy trial. Adult patients
with previous poor bowel preparation (BBPS<6) will be invited to participate in
our study (n=40). Patients willing to participate will receive a limited bowel
preparation (2-days of dietary restrictions + 2x 10 mg bisacodyl + 150ml
picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu. The
BBPS will be assessed before and after segmental washing by the endoscopist who
performs the procedure and later by an independent endoscopist (photos).

Pure-Vu

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) with the Pure-Vu are believed to be equivalent to
conventional colonoscopy, including bleeding and perforation risks.
[unpublished results; publishing date 01/2019 in endoscopy] Participation in
this study could potentially benefit colonoscopy patients because the Pure-Vu
is expected to improve the quality of colonoscopy. Inadequate bowel cleansing
may be prevented by the Pure-Vu. Inadequate bowel cleansing is associated with
lower adenoma detection rates (ADR), lower completion rates, longer procedure
times, more complications and a higher need for repeat procedures.(4, 5) In
addition, Pure-Vu reduces the reliance on patients pre-procedural bowel
preparation which is often considered the most deterrent part of colonoscopy by
patients.