Adenoma Colon
Conditions
Keywords
adenoma detection rate, screening colonoscopy
Brief summary
The Endocuff study aims to show an increase of the number of detected adenomas in screening colonoscopies when a endocuff vision (Arc Medical Design Ldt Leeds England) is used.
Detailed description
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope. Several minor studies have shown that the use of Endocuff probably increases the number of detected polyps in colonoscopy. Endocuff is made of soft plastic and has been designed to give an optimal view of the entire colon. It gently averts and flattens folds in order to see small polyps hiding in the space behind colonic folds. The purpose of this study is to investigate into the effect of the Endocuff in screening colonoscopy compared with screening colonoscopy performed without Endocuff. The device has been used during several years yet an effect on the number of polyps detected during screenings colonoscopy has not been shown. This studies main hypothesis is that the use of Endocuff in screenings colonoscopy will increase the adenoma detection rate in these patients, with a potential to reduce interval cancer. This study is a randomized controlled trial with 900 patients.
Interventions
DEVICEendocuff
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.
PROCEDUREno endocuff
colonoscopy is performed without endocuff.
Sponsors
Herning Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
participant, care provider, investigator and outcomes assessor know whether or not a endocuff has been used for the colonoscopy
Intervention model description
this is a randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* all Citizens participating in the national bowel screening program
Exclusion criteria
* persons who are disabled and who do not understand the Danish language * persons treated with Marcoumar, Marevan, Eliquis, Pradaxa e.g. and who are not eligible to polyp resection * persons who due to diseases of the eyes or Heart are not allowed to receive Buscopan. * persons with active colitis/diverticulitis, colon stenosis e.g. due to cancer, where a complete colonoscopy is not possible to achieve
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adenoma | 2 weeks | number of adenomas found during colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cecal intubation rate | up to 2 hours | is the cecum reached during the colonoscopy |
| cecal intubation time | up to 2 hours | number of minutes from start procedure to cecum reached |
| withdrawal time | up to 60 minutes | number of minutes from cecum reached to end of the procedure, only if no polyps are found |
| adenoma size | up to 4 weeks | size of adenomas detected |
| adenoma site | up to 4 weeks | where in the bowel the adenoma was detected |
Countries
Denmark
Outcome results
None listed