Adenoma Detection Rate in Colonoscopy Performed With EndoRings

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03219918
• Other study ID #: ZUH-KØGE-KIR1
• Status: Terminated
• Phase: N/A
• Start date: June 19, 2017
• Est. completion date: June 7, 2018

Study information

• Verified date: April 2019
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenoma
• Colorectal Neoplasms

Intervention

Device:
• EndoRings II Distal Attachment
Colonoscopy cap

Locations

Country	Name	City	State
Denmark	Zealand University Hospital Køge, Department of Surgery	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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