Clinical trial NCT03219918: Adenoma Detection Rate in Colonoscopy Performed With EndoRings
Official title: Adenoma Detection Rate in Colonoscopy Performed With EndoRings - a Single-centre Prospective Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Adenoma
Colorectal Neoplasms
Keywords: Colorectal adenoma
Colonoscopy
Caps
Adenoma detection rate
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 97
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma detection rate
timeFrame: maximum 60 minutes
Secondary outcomes:
measure: Completion time
timeFrame: maximum 60 minutes
measure: Completion rate
timeFrame: maximum 60 minutes
measure: Malignancy detection
timeFrame: maximum 60 minutes
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital Køge, Department of Surgery
Study officials:
affiliation: Zealand University Hospital Køge
name: Line E Line, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zealand University Hospital Køge
name: Ismayil Gögenur, Prof, DMSc
role: STUDY_DIRECTOR
References: