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

40 Years
65 Years
Open (Enrolling)
Polyps, Neoplasms, Inflammatory Bowel Disease

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

Diagnostic accuracy of innovative colonoscopy

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Miroslaw Szura, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

I Department of General Surgery, Jagiellonian University


Poland: Ministry of Health

Study ID:

Innovations in colonoscopy



Start Date:

September 2012

Completion Date:

December 2013

Related Keywords:

  • Polyps
  • Neoplasms
  • Inflammatory Bowel Disease
  • narrow band imaging
  • dual focus
  • responsive insertion technique
  • scope guide
  • colonoscopy
  • colorectal cancer screening
  • Neoplasms
  • Inflammatory Bowel Diseases
  • Intestinal Diseases