Colonic Neoplasms, Adenomas Serrated, Colo-rectal Cancer, Colon Adenoma
Conditions
Keywords
colonic adenoma, serrated polyps, caecal intubation time, withdrawal time, polyp miss rate
Brief summary
A randomised back to back study comparing cap and Endocuff to detect adenomas during colonoscopy
Interventions
DEVICEEndocuff
It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination
DEVICEcap assisted colonoscopy (CAC)
cap assisted colonoscopy (CAC)
Sponsors
London North West Healthcare NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Intervention model description
It is a randomised back to back study to compare the performance of cap assisted colonoscopy (CAC) and Endocuff assisted colonoscopy (EAC)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18 years and over 2. Referral for surveillance, or diagnostic colonoscopy 3. Ability to give informed consent
Exclusion criteria
1. Absolute contraindications to colonoscopy 2. Established or suspicion of large bowel obstruction or pseudo-obstruction 3. Known colon cancer or polyposis syndromes 4. Known colonic strictures 5. Known severe diverticular segment (that is likely to impede colonoscope passage) 6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis) 7. Patients lacking capacity to give informed consent 8. Pregnancy 9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma miss rate | 1 day | Comparison of adenoma miss rate between cap ( CAC) and Endocuff assisted colonoscopy(E |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean adenoma per procedure | 1 day | Difference in mean adenomas detected per procedure (MAP) between EAC and CAC. |
| Endocuff or cap exchange | 1 day | Number of times Cap or Endocuff are removed to complete the procedure |
| miss rate of advanced polyps | 1 day | Comparison of miss rates of advanced adenomas, serrated polyps and proxima polyps between CAC and EAC |
| Comfort score | 1 day | Comparison of patient comfort score between CAC and EAC |
| Ceacal intubation and withdrawal time | 1 day | Comparison of caecal intubation and withdrawal time |
Other
| Measure | Time frame | Description |
|---|---|---|
| comparison of surveillance intervals | Once histology is available usually takes 10-14 days | To compare any surveillance interval difference between CAC and EAC |
Countries
United Kingdom
Outcome results
None listed