Trial on Innovative Technologies in Colonoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Randomised Trial Comparing New Technologies of Endoscopic Bowel Visualisation With Conventional Colonoscopy.

Conditions
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Polyps, Neoplasms, Inflammatory Bowel Disease

Intervention / Treatment
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* Device: Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)
* Device: Conventional colonoscopy (Olympus CF-H180DL)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Innovative colonoscopy<br>Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus). | Device: Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)<br>* NBI and Dual Focus options will be used to classify lesions according to Sano and Kudo classifications.<br>|
| Active Comparator: Conventional colonoscopy<br>Conventional colonoscopy performed without innovative techniques assessed in this study. | Device: Conventional colonoscopy (Olympus CF-H180DL)<br>* Conventional colonoscopy performed without innovative techniques used in experimental arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of innovative colonoscopy | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total examination time | Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy. | 8-20 minutes | 
| Coecal intubation time | Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot. | 5-15 minutes | 
| Pain intensity (VAS scale) | 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. | 0-10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dual focus, narrow band imaging, responsive insertion technique, scope guide, colonoscopy, colorectal cancer screening