This study will give an overview of the applicability of CCE in colorectal cancer screening. It will be the first implementation of CCE in the Dutch colorectal cancer screening programme. No quantative hypotheses are formed.
ID
Bron
Verkorte titel
Aandoening
This study focuses on colorectal cancer screening (including the diagnostic yield for polyps and colorectal cancer).
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
To evaluate the applicability of CCE in colorectal cancer screening in terms of: diagnostic yield, participation rate, patients’ expected and perceived burden of CCE, the workability of CCE for the staff and the interobserver variability in reviewing the CCE images.
Interested patients who meet all inclusion- and exclusion criteria will get an appointment to undergo Colon Capsule Endoscopy. Patients expected and perceived burden of CCE will be measured by 2 questionnaires, one prior to the procedure and one afterwards. The workability for the staff will be measured by a questionnaire which will be handed out to all staff working with CCE within this trial.
Achtergrond van het onderzoek
The aim of this prospective cohort study is to evaluate the applicability of Colon Capsule Endoscopy (CCE) in the Dutch colorectal cancer screening programme in participants with a positive FIT who have a contra-indication for subsequent colonoscopy, who are unwilling to undergo colonoscopy or who had a prior incomplete screening colonoscopy.
Doel van het onderzoek
This study will give an overview of the applicability of CCE in colorectal cancer screening. It will be the first implementation of CCE in the Dutch colorectal cancer screening programme. No quantative hypotheses are formed.
Onderzoeksopzet
Measure moments:
Timepoint 1: Questionnaire regarding expected burden prior to Colon Capsule Endoscopy.
Timepoint 2: Colon Capsule Endoscopy procedure
Timepoint 3: Questionnaire regarding perceived burden after Colon Capsule Endoscopy.
Timepoint 4: After all inclusions we ask the staff that worked on the trial to fill in the questionnaire about workability for the staff.
Onderzoeksproduct en/of interventie
Colon Capsule Endoscopy
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from
participation in this study:
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 <30 ml/min/1.73m2
5. Congestive heart failure NYHA class III or IV
6. Dysphagia or other swallowing disorder which makes it impossible to swallow the
capsule
7. High risk of capsule retention: IBD, personal history of gastrointestinal surgery other
than uncomplicated procedures that would be unlikely to lead to bowel obstruction
based on the clinical judgment of the investigator
8. Cardiac pacemakers or other implanted electro-medical equipment
9. An MRI scheduled within 14 days after ingestion of the capsule
10. Patients with diagnosed or suspected Congenital Long QT Syndrome
11. Patients with concomitant use of drugs that prolong the QT interval
12. Patients with insulin dependent diabetes
13. Patients with manifest hyperthyroidism
14. Patients with an allergy or hypersensitivity for iodinated agents
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8795 |
| Ander register | METC Erasmus MC : MEC-2019-0159 |