NCT03219918

Adenoma Detection Rate in Colonoscopy Performed With EndoRings

Adenoma Detection Rate in Colonoscopy Performed With EndoRings - a Single-centre Prospective Randomised Clinical Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 97 (actual)
• Sponsor: Zealand University Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 74 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Adenoma
• Colorectal Neoplasms

Interventions

Type	Name	Description
DEVICE	EndoRings II Distal Attachment	Colonoscopy cap

Timeline

• Start date: 2017-06-19
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2017-07-18
• Last updated: 2019-04-11

Locations

1 site across 1 country: Denmark