COlon Capsule Endoscopy as an AlterNative for CT-colonography in Colorectal Cancer Screening

COlon Capsule Endoscopy as an AlterNative for CT-colonography in Colorectal Cancer Screening - The OCEAN Trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55511

Enrollment

100

Registered

2020-04-29

Start date

2020-08-25

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal cancer colorectal neoplasm

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Participation in the Dutch national CRC screening programme 2. Positive result on FIT screening 3. Contra-indications to undergo colonoscopy or sedation OR 4. Not willing to undergo colonoscopy OR 5. Prior incomplete colonoscopy

Exclusion criteria

Exclusion criteria: 1. Inability or refusal to provide informed consent 2. Persons with a severe or terminal disease with a life-expectancy of less than 5 years 3. An allergy or any other known contraindication to the medication used in this study 4. Renal failure, eGFR

Design outcomes

Primary

Measure	Time frame
To evaluate the applicability of Colon Capsule Endoscopy in patients screened positive with a fecal immunochemical test (FIT) who have a contra-indication for subsequent colonoscopy, who are unwilling to undergo colonoscopy or who had a prior incomplete colonoscopy within the Dutch colorectal cancer screening setting by: a. Evaluating diagnostic yield of Colon Capsule endoscopy b. Evaluating the participation rate of the Colon Capsule endoscopy c. Evaluating the expected- and perceived burden of Colon Capsule Endoscopy. d. Evaluating the workability for the staff of Colon Capsule Endoscopy. e. Evaluating the interobserver variability between different reviewers of Colon Capsule Endoscopy.	—

Measure

Time frame

To evaluate the applicability of Colon Capsule Endoscopy in patients screened positive with a fecal immunochemical test (FIT) who have a contra-indication for subsequent colonoscopy, who are unwilling to undergo colonoscopy or who had a prior incomplete colonoscopy within the Dutch colorectal cancer screening setting by: a. Evaluating diagnostic yield of Colon Capsule endoscopy b. Evaluating the participation rate of the Colon Capsule endoscopy c. Evaluating the expected- and perceived burden of Colon Capsule Endoscopy. d. Evaluating the workability for the staff of Colon Capsule Endoscopy. e. Evaluating the interobserver variability between different reviewers of Colon Capsule Endoscopy.

—

Secondary

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results