Trial on Innovative Technologies in Colonoscopy (RCT-IC)

October 6, 2016 updated by: Miroslaw Szura, Jagiellonian University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolska
      • Krakow, Malopolska, Poland, 30-307
        • Specialist Diagnostic and Therapeutic Center MEDICINA
      • Krakow, Malopolska, Poland, 31-501
        • I Department of General Surgery, Jagiellonian University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Innovative colonoscopy
Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus).
Device: 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.
Active Comparator: Conventional colonoscopy
Conventional colonoscopy performed without innovative techniques assessed in this study.
Device: Conventional colonoscopy (Olympus CF-H180DL)
Conventional colonoscopy performed without innovative techniques used in experimental arm.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total examination time
Time Frame: 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.
8-20 minutes
Coecal intubation time
Time Frame: 5-15 minutes
Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.
5-15 minutes
Pain intensity (VAS scale)
Time Frame: 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.
0-10

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity of innovative colonoscopy
Time Frame: 1 year
The sensitivity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.
1 year
Specificity of innovative colonoscopy
Time Frame: 1 year
The specificity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.
1 year
Positive predictive Value (PPV) od innovative colonoscopy
Time Frame: 1 year
The positive predicting value of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
1 year
Negative predicting value (NPV) of innovative colonoscopy
Time Frame: 1 year
The negative predictive value (NPV) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
1 year
Youden's index for innovative colonoscopy
Time Frame: 1 year
The Youden's index of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
1 year
Diagnostic odds ratio (DOR) for innovative colonoscopy
Time Frame: 1 year
The diagnostic odds ratio (DOR) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
1 year
Likelihood ratio for positive test results (LR+)
Time Frame: 1 year
The likelihood ratio for positive test results of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
1 year
Likelihood ratio for negative test results (LR-)
Time Frame: 1 year
The likelihood ratio for negative test results (LR-) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.
1 year
Area under the ROC curve (AUC)
Time Frame: 1 year
Area under the ROC curve for innovative colonoscopy will be calculated using StatSoft Statistica 10.0 software.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jagiellonian University

Collaborators

Specialist Diagnostic and Therapeutic Center MEDICINA

Investigators

  • Principal Investigator: Miroslaw Szura, MD, PhD, I Department of General Surgery, Jagiellonian University
  • Study Chair: Radoslaw Pach, MD, PhD, I Department of General Surgery, Jagiellonian University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

September 16, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimate)

September 20, 2012

Study Record Updates

Last Update Posted (Estimate)

October 7, 2016

Last Update Submitted That Met QC Criteria

October 6, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Innovations in colonoscopy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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