Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) Colonoscopes in Daily Practice

Comparison of Newer Colonoscopy Devices With Standard Forward Viewing (SFV) High Definition Colonoscopes in Daily Practice

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)

Study Overview

• Status: Completed
• Conditions: Adenoma Detection Rate
• Intervention / Treatment: Device: difference between colonoscopes

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 4114
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all patient fit for ambulatory colonoscopy

Exclusion Criteria:

• for Endocuff stricturing divertculosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: FUSE; wide angle colonoscope	Device: difference between colonoscopes; patients have been randomly assigned for colonoscopy with FUSE or HD SFV endoscopes with or without Endocuff
Other: HD Pentax i10 colonoscopes; SFV instrument	Device: difference between colonoscopes; patients have been randomly assigned for colonoscopy with FUSE or HD SFV endoscopes with or without Endocuff
Other: Endocuff; Cuff on SFV	Device: difference between colonoscopes; patients have been randomly assigned for colonoscopy with FUSE or HD SFV endoscopes with or without Endocuff

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma detection rate	adenoma counts	within 45 minutes of examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time for endoscopy (time to ileum, withdrawal and intervention time). Medication, Satisfaction on VAS	different endoscopy characteristics	within 45 minutes of examination

Collaborators and Investigators

• Sponsor: Gastroenterologie Baden-Wettingen

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): September 25, 2019
• Study Completion (Actual): September 25, 2019

Study Registration Dates

• First Submitted: July 11, 2020
• First Submitted That Met QC Criteria: July 11, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: GastroBaWe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No