The ADENOMA study - a study of a device to improve detection of polyps during colonoscopy
Not Applicable
Completed
- Conditions
- Conditions requiring colonoscopy assessment, colonic adenomasDigestive System
- Registration Number
- ISRCTN11821044
- Lead Sponsor
- South Tyneside NHS Foundation Trust (UK)
- Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29363535
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 1772
Inclusion Criteria
1. Age 18 years and over
2. Referral for screening, 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 would be likely to prevent passage of the colonoscope)
6. Patients with acute colitis (ulcerative, Crohn?s and diverticulitis)
7. Patients lacking capacity to give informed consent
8. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Adenoma detection rate (ADR)
- Secondary Outcome Measures
Name Time Method <br> 1. Mean adenomas detected per procedure (MAP)<br> 2. The rate of cuff exchange (that is, how often the cuff has to be removed)<br> 3. Caecal intubation rates and insertion time to terminal ileum (to demonstrate non-inferiority)<br> 4. Complete withdrawal time in procedures where no polyps are detected (to demonstrate non-inferiority)<br> 5. Patient satisfaction<br> 6. To identify any difference in future colonoscopic workload produced by increased adenoma detection rate in terms of number of potential follow-up procedures based on BSG adenoma surveillance guidelines between the EAC and SC groups<br>