Adenoma Detection Rate in Colonoscopy Performed With EndoRings

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-19

Study Completion Date

2018-06-07

Brief Summary

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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.

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Detailed Description

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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

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Colorectal Adenoma Colorectal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a single-centre prospective randomised clinical trial. Patients are included if they meet the specified inclusion criteria and accept to take part in the study after proper oral and written information (see patient information below).

Specimens i.e. removed adenomas and biopsies of suspected malignancies are analysed by pathologists according to standard procedure. The pathologist will not know the nature of specimen collection (colonoscopy with or without EndoRings). The specimens are not saved for any other study related activities.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

It is partially blinded in the way that the endoscopist knows whether the procedure is performed with or without the EndoRings but neither patient, pathologist nor investigators will have this information, which is only to be revealed to the investigators at the end of data processing.

Study Groups

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With EndoRings

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

Group Type ACTIVE_COMPARATOR

EndoRings II Distal Attachment

Intervention Type DEVICE

Colonoscopy cap

NO EndoRings

Colonoscopy is performed conventionally without any caps

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EndoRings II Distal Attachment

Colonoscopy cap

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes