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| Name | Class |
|---|---|
| Specialist Diagnostic and Therapeutic Center MEDICINA | UNKNOWN |
| Jagiellonian University | OTHER |
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The aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical practice.
The important elements of this evaluation are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Innovative colonoscopy | Experimental | Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus) |
|
| Conventional colonoscopy | Active Comparator | Conventional colonoscopy performed without innovative techniques assessed in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus) | Device | NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE classifications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 NICE and Kudo classification during colonoscopy and results will be compared with histologic examination. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cecal intubation time |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miroslaw Szura, MD, PhD | Contact | 609210030 | msszura@gmail.com | |
| Artur Pasternak, MD, PhD | Contact | 603642620 | artur.pasternak@uj.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Miroslaw Szura, MD, PhD | Department of Experimental and Clinical Surgery, Jagiellonian University Medical College, | Principal Investigator |
| Artur Pasternak, MD, PhD | Department of Anatomy, Jagiellonian University Medical College |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Specialist Diagnostic and Therapeutic Center MEDICINA | Recruiting | Krakow | Malopolska | 30-307 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34136023 | Derived | 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. |
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| ID | Term |
|---|---|
| D011127 | Polyps |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062048 | Narrow Band Imaging |
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Conventional colonoscopy (Olympus CF-H180DL) | Device | Conventional colonoscopy performed without innovative techniques used in experimental arm. |
|
Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.
| 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. | immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure |
| D008919 |
| Investigative Techniques |