NCT03254498CompletedNot Applicable
Is Endocuff Vision Assisted Colonoscopy Superior to Cap Assisted Colonoscopy to Detect Adenomas
London North West Healthcare NHS Trust2 sites in 1 country154 target enrollmentStarted: April 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 154
- Locations
- 2
- Primary Endpoint
- Adenoma miss rate
Study Overview
Brief Summary
A randomised back to back study comparing cap and Endocuff to detect adenomas during colonoscopy
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age 18 years and over
- •Referral for surveillance, or diagnostic colonoscopy
- •Ability to give informed consent
Exclusion Criteria
- •Absolute contraindications to colonoscopy
- •Established or suspicion of large bowel obstruction or pseudo-obstruction
- •Known colon cancer or polyposis syndromes
- •Known colonic strictures
- •Known severe diverticular segment (that is likely to impede colonoscope passage)
- •Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
- •Patients lacking capacity to give informed consent
- •Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure
Outcomes
Primary Outcomes
Adenoma miss rate
Time Frame: 1 day
Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E
Secondary Outcomes
- Mean adenoma per procedure(1 day)
- miss rate of advanced polyps(1 day)
- Endocuff or cap exchange(1 day)
- Ceacal intubation and withdrawal time(1 day)
- Comfort score(1 day)
Investigators
Study Sites (2)
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