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Completed

NCT Number: NCT01688557

Trial on Innovative Technologies in 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.

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Key information

Conditions

Polyps Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Disease Inflammatory Bowel Diseases Intestinal Diseases Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

I Department of General Surgery, Jagiellonian University, Krakow, Malopolska, Poland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Conventional colonoscopy (Olympus CF-H180DL)

Device

Conventional colonoscopy performed without innovative techniques used in experimental arm.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Coecal intubation time

    Time frame: 5-15 minutes

    Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.

  3. 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.

Other outcomes

  1. Sensitivity of innovative colonoscopy

    Time frame: 1 year

    The sensitivity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.

  2. Specificity of innovative colonoscopy

    Time frame: 1 year

    The specificity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Collaborators

  • Specialist Diagnostic and Therapeutic Center MEDICINA

Registry information

Official study title

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

Acronym: RCT-IC

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 20, 2012
Registry last updated
Oct 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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