Completed

RCT-ICProspective Randomised Trial Comparing New Technologies of Endoscopic Bowel Visualisation With Conventional Colonoscopy.

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What is being tested

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

+ Conventional colonoscopy (Olympus CF-H180DL)

Device
Who is being recruted

Digestive System Diseases+6

+ Gastroenteritis

+ Gastrointestinal Diseases

From 40 to 65 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorJagiellonian University
Last updated: October 7, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

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.

NCT01688557
Principal SponsorJagiellonian University
Last updated: October 7, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

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

600 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 40 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesPathological Conditions, Signs and SymptomsPathological Conditions, AnatomicalNeoplasmsPolypsInflammatory Bowel Diseases

Criteria

3 inclusion criteria required to participate
no colonoscopy during last 10 years
no previous abdominal surgery
written informed consent
10 exclusion criteria prevent from participating
ASA > IV
age < 40 and > 65 years
cirrhosis (Child B or C) or ascites
colonoscopy performed during last 10 years
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Active Comparator
Conventional colonoscopy performed without innovative techniques assessed in this study.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Specialist Diagnostic and Therapeutic Center MEDICINA

Krakow, PolandOpen Specialist Diagnostic and Therapeutic Center MEDICINA in Google Maps

I Department of General Surgery, Jagiellonian University

Krakow, Poland
Completed2 Study Centers