Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2016-06-30
2018-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Innovative colonoscopy
Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus)
Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)
NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE classifications.
Conventional colonoscopy
Conventional colonoscopy performed without innovative techniques assessed in this study.
Conventional colonoscopy (Olympus CF-H180DL)
Conventional colonoscopy performed without innovative techniques used in experimental arm.
Interventions
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Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)
NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE classifications.
Conventional colonoscopy (Olympus CF-H180DL)
Conventional colonoscopy performed without innovative techniques used in experimental arm.
Eligibility Criteria
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Inclusion Criteria
* no previous abdominal surgery
* no colonoscopy during last 10 years
Exclusion Criteria
* 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
* IBD
* GI neoplastic disease
40 Years
65 Years
ALL
No
Sponsors
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Specialist Diagnostic and Therapeutic Center MEDICINA
UNKNOWN
Jagiellonian University
OTHER
Miroslaw Szura
OTHER
Responsible Party
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Miroslaw Szura
Associate Professor
Principal Investigators
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Miroslaw Szura, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Experimental and Clinical Surgery, Jagiellonian University Medical College,
Artur Pasternak, MD, PhD
Role: STUDY_CHAIR
Department of Anatomy, Jagiellonian University Medical College
Locations
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Specialist Diagnostic and Therapeutic Center MEDICINA
Krakow, Malopolska, Poland
Countries
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Central Contacts
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Facility Contacts
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References
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Bogacki P, Gach T, Krzak J, Szura M. Panoramic colonoscopy in colorectal cancer screening - a randomized controlled trial. Wideochir Inne Tech Maloinwazyjne. 2021 Jun;16(2):289-296. doi: 10.5114/wiitm.2021.103922. Epub 2021 Feb 25.
Other Identifiers
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ADVANCED ENDOSCOPIC IMAGING
Identifier Type: -
Identifier Source: org_study_id
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