Patients diagnosed with adenomas at colonoscopy, including those with low-risk adenoma(s) (one or two small adenomas), intermediate-risk adenoma(s) (three or four small adenomas, or one or two large adenomas) or high-risk adenoma(s) (five or more small adenomas, or three or more large adenomas) Cancer Adenoma
Conditions
Interventions
Routinely reported UK hospital data on gastrointestinal endoscopy and pathology data are collected for consecutive patients having diagnostic and surveillance procedures to identify the study cohort (
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 22/06/2017: 1. Men and women 2. Any age 3. With low-, intermediate- or high-risk adenomas who have undergone a baseline colonoscopy Previous inclusion criteria: 1. Men and women 2. Any age 3. With intermediate adenomas who have undergone a baseline colonoscopy
Exclusion criteria
Exclusion criteria: 1. Any of the following diagnoses at, or prior to, baseline: 1.1. CRC or inflammatory bowel disease (IBD) 1.2. Resection/anastomosis 1.3. Volvulus 2. Any of the following diagnoses at any time: 2.1. Family history of familial adenomatous polyposis (FAP) 2.2. HNPCC 2.3. Cowden syndrome 2.4. Juvenile or hamartomatous polyps 3. Patients with polyposis could be excluded depending on polyposis type and time of diagnosis 4. No baseline colonoscopy 5. One or more procedures without a date 6. More than 40 endoscopic procedures recorded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 22/06/2017: Incidence of adenomas, advanced adenomas and colorectal cancer (CRC) at follow-up visits will be measured through medical record review. Long-term CRC incidence will be determined from ONS / NHS Digital / NHS NSS and PHE-ODR data. Previous primary outcome measures: Incidence of adenomas, advanced adenomas and colorectal cancer (CRC) at follow-up visits will be measured through medical record review and long-term CRC incidence will be determined from ONS/HSCIC data. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Psychological impact (anxiety, bowel cancer worry, number of GP visits and bowel symptoms) was measured using a questionnaire sent to participants who took part in the UKFSST screening study 6-months before screening and 3-6 months after screening 2. The health-economic analysis will take the form of an incremental cost-effective analysis of intermediate risk patients in the hospital data set, using a state-transition model. Two key health economic outcomes will be reported – cost per cancer avoided and cost per life year saved. | — |
Countries
England, United Kingdom
Contacts
Public ContactAmanda Cross
Outcome results
None listed