Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04472741 |
| Other study ID # |
GastroBaWe |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2015 |
| Est. completion date |
September 25, 2019 |
Study information
| Verified date |
February 2021 |
| Source |
Gastroenterologie Baden-Wettingen |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Retrospective data analysis of comparsion of 3 types of colonoscopes in daily practice (FUSE
Full spectrum colonoscopy with 330° angle of view vs Pentax standard HD-colonoscopes and
Pentax plus Endocuff): medical device of the category IIb (CE-marked device used within its
intended purpose)
Description:
From March 2015 through February 2017 (phase A) patients referred for ambulant colonoscopy in
a private Swiss gastroenterologist's practice were alternatingly allocated to one of the two
endoscopy theatres. One equipped with a FUSE® endoscopy system from Endochoice (later: Boston
Scientific, nA/FUSE®=1044 examinations), the other with an EPKi Processor and Pentax i10
colonoscopes (nA/Pentax=934 examinations). In March 2017 a second doctor joined the practice,
but did not contribute to the study. These organizational changes required randomization to
be switched from per-patient alternation to per-day alternation in phase B from March 2018
through September 2019. In phase B the FUSE® system was unchanged (nB/FUSE®=1386
examinations), while the Pentax i10 colonoscopes were additionally equipped with Endocuff®
(nB/Endocuff®=750 examinations). Patients with contraindica-tion against Endocuff® (known or
found diverticular stenosis) were excluded from the study (nB/removed=127). Patients were
given their appointments to any free slot throughout the week without stratification. The
study and data analysis was consented by the ethical committee EKNZ Ethikkom-mission
Nordwest- und Zentralschweiz (Project-ID 2019-01643).
All procedures were performed by one experienced endoscopist (board certified 2004) under
nurse assisted propofol sedation (NAPS).
Baseline characteristics, age, sex, BMI, smoking habits, diabetes as well as quality of bowel
prepara-tion (measured by BBPS score) and indication for colonoscopy (screening,
surveillance, diagnostic, such as diarrhea, bleeding, persistent abdominal pain) were
assessed. Amount of sedatives, other medications given during endoscopy (e.g. Buscopan®) and
time for the endoscopy e.g. time to ile-um, retraction time (pullback time minus intervention
time) and time for intervention were measured by the assistant with a stopwatch. These
parameters, polyp counts, size and their localisation (entered in a table and to an
anatomical scheme), and satisfaction for all parts of the examination (bowel prep and overall
satisfaction) were realtime entered to the database by a tablet computer. The data entry was
done coded. Only the main investigator could subdue each single patient.
Statistics were done with a professional statistics, the co-author Dr. Leiner
