Trial on Innovative Technologies in Colonoscopy

Not Applicable

Completed

• Conditions: Inflammatory Bowel Disease; Polyps; Neoplasms
• Interventions: Device: Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus); Device: Conventional colonoscopy (Olympus CF-H180DL)

• Registration Number: NCT01688557
• Lead Sponsor: Jagiellonian University

Brief Summary

The trial will compare results of screening colonoscopy performed by means of conventional colonoscopy and using new visualisation techniques during endoscopic examination.

* Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band imaging (NBI) will be used for innovative colonoscopies

* Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used for conventional colonoscopies Endoscopists will archive all images and establish presumptive diagnosis based on the results of different visualisation techniques. All endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological lesions will be performed to establish final diagnosis. The main outcome measure is diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.

Detailed Description

A total of 600 consecutive patients undergoing screening unsedated colonoscopy will be randomly assigned to innovative or conventional examination. Randomization will be based on computer-generated randomization lists. All patients will be blinded so they will not know which techniques will be used to assess lesions found in colon. In innovative colonoscopy group narrow band imaging (NBI) and Dual Focus (DF) function will be used to identify and classify all lesions acc. to Sano and Kudo classification. Endoscopic biopsy will be taken from all lesion and endoscopic diagnosis will be compared with final histological diagnosis. Thus sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and Youden index will be calculated. As secondary endpoints total examination time, coecal intubation rate and pain intensity (VAS scale) will be established. This study will help to establish whether new technologies used during colonoscopy may improve diagnostic possibilities and whether they prolong examination time or lead to increase of pain intensity afterwards.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-16
• Study First Submitted QC: 2012-09-19
• Study First Posted: 2012-09-20
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

• written informed consent
• no previous abdominal surgery
• no colonoscopy during last 10 years

Exclusion Criteria

• age < 40 and > 65 years
• large bowel resection in history
• colonoscopy performed during last 10 years
• contraindications for general anaesthesia
• ASA > IV
• pregnancy
• confirmed neoplastic disease
• cirrhosis (Child B or C) or ascites
• immunosuppressive therapy or steroids intake
• malabsorption syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Innovative colonoscopy	Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)	Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus).
Conventional colonoscopy	Conventional colonoscopy (Olympus CF-H180DL)	Conventional colonoscopy performed without innovative techniques assessed in this study.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of innovative colonoscopy	1 year	Diagnostic accuracy of innovative techniques used during colonoscopy (narrow band imaging and double focus option) will be assessed using StatSoft Statistica 10.0 software. All lesions will be classified acc. to Sano and Kudo classification during colonoscopy and results will be compared with histologic examination.

Secondary Outcome Measures

Name	Time	Method
Total examination time	8-20 minutes	Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy.
Coecal intubation time	5-15 minutes	Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.
Pain intensity (VAS scale)	0-10	Pain intensity will be assessed during and after each colonoscopy using the Visual Analogue Scale. It will be assessed immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure.

Trial Locations

Locations (2)

Specialist Diagnostic and Therapeutic Center MEDICINA; 🇵🇱 Krakow, Malopolska, Poland

I Department of General Surgery, Jagiellonian University; 🇵🇱 Krakow, Malopolska, Poland