Differences in Preparation for Small Bowel Capsule Endoscopy
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The introduction of video capsule endoscopy in 2000 has provided a convenient and minimally
invasive imaging method for the whole small bowel. Capsule Endoscopy is used to investigate a
number of conditions such as obscure gastrointestinal bleeding, iron deficiency anaemia,
inflammatory bowel disease, celiac disease, small bowel tumors, and hereditary polyposis
syndromes. However, Capsule Endoscopy capsules are not able to suction fluid or wash the
intestine, thus making it susceptible to decreased visualization quality and diagnostic yield
due to dark intestinal contents or air bubbles. In order to determine the best method for
bowel preparation before Capsule Endoscopy, this study seeks to determine in patients
undergoing small intestine Capsule Endoscopy if split dose Polyethylene Glycol or single
morning dose of Polyethylene Glycol have a benefit in Visualisation quality when compared to
clear fluids only. A co-primary outcome will also be the diagnostic yield, as measured by the
aggregate of all the active preparation groups compared to than clear fluids only group.
Secondary outcome measures will include tolerance of preparations, cleanliness as assessed by
a validated 4 point scale, distal small bowel visualization (the last 1/4 of small bowel
examination by time) and small bowel transit time (measured as time from first duodenal image
to first cecal image). Adult outpatients referred for small bowel video capsule endoscopy
will be considered for the study and this will run in the clinical environment as per
routine. Patients will have been referred for capsule endoscopy as per normal clinical
practice so not additional procedure will take place. Patients will be randomly assigned to
in a one to one fashion to one of three groups in order to explore whether bowel preparation
(either as a single or divided dose) produce better cleansing and diagnostic yield than no
preparation at all in small bowel capsule endoscopy.