The aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical practice. The important elements of this evaluation are: * Evaluation of the character of neoplastic lesions in the colon based on different imaging techniques * Verification of the endoscopic image with histopathologic descriptions * Establishing the type of the lesion on the basis of Kudo and NICE classifications * Comparison of the result of histopathological examination with the macroscopic type of the lesion * Determination of the most advanced lesions (MAL) * Comparison of the cecal intubation time * Evaluation of the type of anesthesia used during colonoscopy * Subjective assessment of the severity of pain according to VAS (visual analogue scale) * Comparison of the accuracy of the location of lesions on the basis of endoscopic navigation * Comparison of the total examination time * Comparison of adenoma detection rate
A total of 400 consecutive patients undergoing unsedated colonoscopy as a part of a national colorectal cancer screening program 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 according. to Kudo and NICE classification. Endoscopic biopsy samples will be taken from all lesions and in vivo endoscopic diagnosis will be compared with final histopathological result. Thus, sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and Youden index will be calculated. As secondary endpoints total examination time, cecal intubation rate and pain intensity (VAS) will be determined. This study will help to establish whether advanced imaging 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
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
400
NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE classifications.
Conventional colonoscopy performed without innovative techniques used in experimental arm.
Specialist Diagnostic and Therapeutic Center MEDICINA
Krakow, Malopolska, Poland
RECRUITINGDiagnostic accuracy of innovative colonoscopy
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 NICE and Kudo classification during colonoscopy and results will be compared with histologic examination.
Time frame: 1 year
Total examination time
Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy.
Time frame: 8-20 minutes
Cecal intubation time
Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.
Time frame: 5-15 minutes
Pain intensity (VAS scale)
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.
Time frame: immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.