Ignite Creation Date:
2024-05-06 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03219918
Status:
TERMINATED
Last Update Posted:
2019-04-11
First Post:
2017-06-13
Brief Title:
Adenoma Detection Rate in Colonoscopy Performed With EndoRings
Sponsor:
Zealand University Hospital
Organization:
Zealand University Hospital
Study Overview
Official Title:
Adenoma Detection Rate in Colonoscopy Performed With EndoRings - a Single-centre Prospective Randomised Clinical Trial
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Practically difficult to inroll the number of patients anticipated
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None