Colorectal Neoplasms Clinical Trial
Official title:
Adenoma Detection Rate in Colonoscopy Performed With EndoRings - a Single-centre Prospective Randomised Clinical Trial
Verified date | April 2019 |
Source | Zealand University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 97 |
Est. completion date | June 7, 2018 |
Est. primary completion date | June 7, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 74 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Zealand University Hospital Køge, Department of Surgery | Køge |
Lead Sponsor | Collaborator |
---|---|
Zealand University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adenoma detection rate | Number of colorectal adenomas/neoplasms/carcinomas found in colonoscopy | maximum 60 minutes | |
Secondary | Completion time | Overall colonoscopy duration | maximum 60 minutes | |
Secondary | Completion rate | Colonoscopy completion (intubation to coecum) | maximum 60 minutes | |
Secondary | Malignancy detection | Number of colorectal malignancies found in colonoscopy | maximum 60 minutes |
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