The ADENOMA study - a study of a device to improve detection of polyps during colonoscopy

Conditions

Conditions requiring colonoscopy assessment, colonic adenomas Digestive System

Wee Sing Ngu, Roisin Bevan, Zacharias Tsiamoulos, Paul Bassett, Zoë Hoare et al. (15 authors)

Gut2018-01-23135 citations

10.1136/gutjnl-2017-314889

The ADENOMA Study. Accuracy of Detection using Endocuff Vision™ Optimization of Mucosal Abnormalities: study protocol for randomized controlled trial

Roisin Bevan, Wee Sing Ngu, Brian Saunders, Zacharias Tsiamoulos, Paul Bassett et al. (7 authors)

Endoscopy International Open2015-11-2713 citations

10.1055/s-0041-107900

Interventions

Two study arms: 1. Control arm - routine colonoscopy performed in standard fashion with no Endocuff Vision attached to scope 2. Intervention arm - colonoscopy performed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18 years and over 2. Referral for screening, surveillance or diagnostic colonoscopy 3. Ability to give informed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Adenoma detection rate (ADR)	—

Secondary

Measure	Time frame
1. Mean adenomas detected per procedure (MAP) 2. The rate of cuff exchange (that is, how often the cuff has to be removed) 3. Caecal intubation rates and insertion time to terminal ileum (to demonstrate non-inferiority) 4. Complete withdrawal time in procedures where no polyps are detected (to demonstrate non-inferiority) 5. Patient satisfaction 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	—

Measure

Time frame

1. Mean adenomas detected per procedure (MAP) 2. The rate of cuff exchange (that is, how often the cuff has to be removed) 3. Caecal intubation rates and insertion time to terminal ileum (to demonstrate non-inferiority) 4. Complete withdrawal time in procedures where no polyps are detected (to demonstrate non-inferiority) 5. Patient satisfaction 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

—

Countries

United Kingdom

Outcome results

None listed