Neoplasms Clinical Trial
— RCT-ICOfficial title:
Prospective Randomised Trial Comparing New Technologies of Endoscopic Bowel Visualisation With Conventional Colonoscopy.
Verified date | October 2016 |
Source | Jagiellonian University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Poland: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 600 |
Est. completion date | September 2016 |
Est. primary completion date | September 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 65 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Poland | I Department of General Surgery, Jagiellonian University | Krakow | Malopolska |
Poland | Specialist Diagnostic and Therapeutic Center MEDICINA | Krakow | Malopolska |
Lead Sponsor | Collaborator |
---|---|
Jagiellonian University | Specialist Diagnostic and Therapeutic Center MEDICINA |
Poland,
Szura M, Pasternak A, Bucki K, Urbanczyk K, Matyja A. Two-stage optical system for colorectal polyp assessments. Surg Endosc. 2016 Jan;30(1):204-14. doi: 10.1007/s00464-015-4186-x. Epub 2015 Apr 4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sensitivity of innovative colonoscopy | The sensitivity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software. | 1 year | No |
Other | Specificity of innovative colonoscopy | The specificity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software. | 1 year | No |
Other | Positive predictive Value (PPV) od innovative colonoscopy | The positive predicting value of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. | 1 year | No |
Other | Negative predicting value (NPV) of innovative colonoscopy | The negative predictive value (NPV) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. | 1 year | No |
Other | Youden's index for innovative colonoscopy | The Youden's index of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. | 1 year | No |
Other | Diagnostic odds ratio (DOR) for innovative colonoscopy | The diagnostic odds ratio (DOR) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. | 1 year | No |
Other | Likelihood ratio for positive test results (LR+) | The likelihood ratio for positive test results of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. | 1 year | No |
Other | Likelihood ratio for negative test results (LR-) | The likelihood ratio for negative test results (LR-) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. | 1 year | No |
Other | Area under the ROC curve (AUC) | Area under the ROC curve for innovative colonoscopy will be calculated using StatSoft Statistica 10.0 software. | 1 year | No |
Primary | Diagnostic 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 Sano and Kudo classification during colonoscopy and results will be compared with histologic examination. | 1 year | No |
Secondary | 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. | 8-20 minutes | No |
Secondary | Coecal intubation time | Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot. | 5-15 minutes | No |
Secondary | 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. | 0-10 | No |
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