Colorectal Adenoma, Colorectal Neoplasms
Conditions
Keywords
Colorectal adenoma, Colonoscopy, Caps, Adenoma detection rate
Brief summary
The study is designed to examine whether colonoscopy using an EndoRings cap has a higher adenoma detection rate than conventional colonoscopy. Secondary end-points is to compare completion rate, completion time, complication rate and detection of malignancies. Half of the patients will be randomised to colonoscopy using cap and the other half to no cap.
Detailed description
Colonoscopy is recognised as the standard method for finding and removing colorectal adenomas, which are precursors of most colorectal cancers. It has been shown that there is a direct correlation between adenoma detection rate and the risk of developing colorectal cancer subsequently. However, patients undergoing colonoscopy are still at risk of developing colorectal cancer, mainly because precursor lesions are missed during the procedure. This may be due to insufficient bowel preparation, difficulties in visualising flat lesions or the location of lesions behind haustral folds. Improving the ADR can be achieved by different means; better training of endoscopists, improved bowel preparation, optimal sedation and medico technical developments. The technical improvements have mainly been in the optimising of image and improved scope thickness and flexibility, including devices that improve visualisation by increasing the exposed colonic surface . One of these new inventions is the EndoRings II Distal Attachment. According to the Danish Colorectal Cancer Screening Database, the ADR of standard screening colonoscopy is between 34 and 67 % with a national average of 49 % of patients with detected adenomas. Due to the known adenoma miss rate in standard screening colonoscopies, it is important to increase the ADR on average as well as finding ways to improve ADR for centres with a lower than average ADR.
Interventions
DEVICEEndoRings II Distal Attachment
Colonoscopy cap
Sponsors
Zealand University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
It is partially blinded in the way that the endoscopist knows whether the procedure is performed with or without the EndoRings but neither patient, pathologist nor investigators will have this information, which is only to be revealed to the investigators at the end of data processing.
Intervention model description
The study is a single-centre prospective randomised clinical trial. Patients are included if they meet the specified inclusion criteria and accept to take part in the study after proper oral and written information (see patient information below). Specimens i.e. removed adenomas and biopsies of suspected malignancies are analysed by pathologists according to standard procedure. The pathologist will not know the nature of specimen collection (colonoscopy with or without EndoRings). The specimens are not saved for any other study related activities.
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
Patients meeting all the below listed criteria are eligible for inclusion in the trial: 1. Age between 50 - 74 years (age range of screening population) 2. Positive HemoCult home test from the Danish Colorectal Cancer Screening Programme 3. Ability to give informed consent to participation in the trial.
Exclusion criteria
Patients meeting one or more of the below listed criteria will be excluded from the trial: 1. History of colorectal cancer 2. History of Inflammatory Bowel Disease 3. Part of other control programme (e.g. HNPCC or adenoma control) 4. ASA =/\> 4 and/or necessity of general anaesthesia 5. Former surgery with removal of a part of the colon on either benign or malignant background
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate | maximum 60 minutes | Number of colorectal adenomas/neoplasms/carcinomas found in colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion time | maximum 60 minutes | Overall colonoscopy duration |
| Completion rate | maximum 60 minutes | Colonoscopy completion (intubation to coecum) |
| Malignancy detection | maximum 60 minutes | Number of colorectal malignancies found in colonoscopy |
Countries
Denmark
Outcome results
None listed