Physician
Rasmus Krøijer
Department of Surgery, Odense University Hospital
| Project management | ||
| Project status | Closed | |
| Data collection dates | ||
| Start | 01.06.2016 | |
| End | 01.06.2018 | |
Colon Capsule endoscopy, screening for neoplasms: intra- and interobserver variation study
Short summary
Worldwide screening for colorectal cancer and adenomas is being implemented. Various methods are used including index sigmoidoscopy, fecal occult blood test and colonoscopy. Citizen participation varies greatly but rarely exceeds 60%. This is thought to be, in part, unwillingness to undergo endoscopic examination of the colon. Colon capsule endoscopy is a new emerging technique where a capsule containing two cameras is swallowed, and the cameras record the intestine and send the videos via Bluetooth to a recorder attached to the person's stomach. New studies are confirming that the capsule has similar accuracy in detecting neoplasms of the colon as colonoscopy. However, there are no studies investigating the intra- and inter-observer variation in the video interpretation and report.
Rationale
Aim: To determine the inter- and intra-observer variation of both novice and expert reviewers of neoplasm recognition and bowel cleansing.
Method: 42 colon capsule endoscopy videos are reviewed by two external expert reviewers and two novice reviewers twice blinded. Video cleansing level and all pathologic findings are reported according to location, size and appearance.
Statistical considerations: To estimate intra-class correlation of per-patient polypamount with a power of 0.85 and a 95% confidence interval of 0.75 to 0.95, a sample size of 32 is needed. To estimate cleansing grade, 4 scales, with both poor cleansed and acceptably cleansed samples an additional 10 poor cleansed samples are added.
Ethical considerations: Patients have already consent to be examined, and to the use of the videos for scientific purpose, by the protocol 'Colon capsule endoscopy, Screening for neoplasms'. And there are as such no implications or patient risk involved in this study. Should any clinically relevant new findings be done, a key-file can combine the video and patient so that any necessary action can be taken.
Description of the cohort
42 colon capsule endoscopy exams from patients undergoing screening for colorectal cancer previously included in the study: OP_205 Colon Capsule Endoscopy of immunochemical fecal occult blood test (IFOBT) positive individuals in a national colorectal cancer screening program.
Data and biological material
42 colon capsule endoscopy videos.
Collaborating researchers and departments
Department of Surgery, Odense University Hospital
- PhD-student Rasmus Krøijer
- PhD-student Marleen Buijs
- Postdoc Morten Kobæk Larsen, PhD
Department of Surgery, Odense University Hospital, Svendborg and Institute of Regional Health Services, University of Southern Denmark
- Professor and Consultant Gunnar Baatrup
Department of Surgery, Odense University Hospital, Svendborg and Institute of Clinical Research, University of Southern Denmark
- Professor and consultant Niels Qvist
Corporate Health, Hamburg, Germany: Providing the capsules and the experienced trained staff to analyze the capsule video.
Sundhed.dk: Providing the data-transmission, storage and processing system approved by the data protection agency.
The department of Innovation, Odense University Hospital: Performs evaluation of economics and logistics.
The Danish Screening database steering group: Has approved and follows the project.
The regional screening office, Region Syddanmark: Collaborate in communication to screening individuals
The OUH management and directors: Part of study group and co-financers
Regional Health Board, Danish Regions: Partners and co-financers.
Health Care, Denmark: IT-solutions, logistics and co-financers
OPEN Odense Patient data Explorative Network, OUH: Secured databases
René dupont Christensen, Institute of Public Health: Statistical advisory and analysis.
Dr. Cristiano Spada, Rome, Italy
Dr. Ignacio Fernandez-Urien, Pamplona, Spain
Publications associated with the project