Adenoma Detection Rate in Colonoscopy Performed With EndoRings

Not Applicable

Terminated

• Conditions: Colorectal Adenoma; Colorectal Neoplasms
• Interventions: Device: EndoRings II Distal Attachment

• Registration Number: NCT03219918
• Lead Sponsor: Zealand University Hospital

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.

Study Timeline

• Study First Submitted: 2017-06-13
• Study Start: 2017-06-19
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-18
• Primary Completion: 2018-06-07
• Study Completion: 2018-06-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With EndoRings	EndoRings II Distal Attachment	Colonoscopy is performed with the use of the cap-device EndoRings II Distal Attachment to be attached to the tip of the colonoscope

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	maximum 60 minutes	Number of colorectal adenomas/neoplasms/carcinomas found in colonoscopy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zealand University Hospital Køge, Department of Surgery; 🇩🇰 Køge, Denmark