Trial on Innovative Technologies in Colonoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-09-30

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.

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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.

Conditions

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Polyps Neoplasms Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Innovative colonoscopy

Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus).

Group Type EXPERIMENTAL

Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)

Intervention Type DEVICE

NBI and Dual Focus options will be used to classify lesions according to Sano and Kudo classifications.

Conventional colonoscopy

Conventional colonoscopy performed without innovative techniques assessed in this study.

Group Type ACTIVE_COMPARATOR

Conventional colonoscopy (Olympus CF-H180DL)

Intervention Type DEVICE

Conventional colonoscopy performed without innovative techniques used in experimental arm.

Interventions

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Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)

NBI and Dual Focus options will be used to classify lesions according to Sano and Kudo classifications.

Intervention Type DEVICE

Conventional colonoscopy (Olympus CF-H180DL)

Conventional colonoscopy performed without innovative techniques used in experimental arm.

Intervention Type DEVICE

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No