Proportion of participants in whom at least one adenoma is detected at colonoscopy, as indicated by the Adenoma Detection Rate (ADR)
Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies to give the ADR. ADR is usually expressed as a percentage.
Number of adenomas per participant detected at colonoscopy in the 'screening' participant population, as indicated by MAP for that participant population.
The number of adenomas identified during each colonoscopy within the 'screening' participant population will be summed and divided by the total number of colonoscopies in that participant population. The MAP for the 'screening' participant population within each study arm will be compared
Number of adenomas per participant detected at colonoscopy in the 'symptomatic' participant population, as indicated by MAP for that participant population
The number of adenomas identified during each colonoscopy within the 'symptomatic' participant population will be summed and divided by the total number of colonoscopies in that participant population to calculate MAP. The MAP for the 'symptomatic' participant population within each study arm will be compared
Proportion of participants in the 'screening' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population
Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant within the 'screening' participant population. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies in that participant population to calculate ADR. The ADR for the 'screening' participant population within each study arm will be compared
Proportion of participants in the 'symptomatic' participant population in whom at least one adenoma is detected at colonoscopy, as indicated by ADR for that participant population
Whether or not at least one adenoma is detected at colonoscopy will be determined for each participant within the 'symptomatic' participant population. The number of colonoscopies where one or more adenomas is identified will be divided by the total number of colonoscopies in that participant population to calculate ADR. The ADR for the 'symptomatic' participant population within each study arm will be compared
Number of polyps per participant detected at colonoscopy, as indicated by the Mean number of Polyps per Procedure (MPP)
The total number of polyps detected during each colonoscopy will be summed, and divided by the total number of colonoscopies, to calculate MPP. MPP is usually expressed as a number to one decimal place.
Number of polyps per participant detected at colonoscopy in the 'screening' participant population, as indicated by the Mean number of Polyps per Procedure (MPP)
The total number of polyps detected during colonoscopy for each participant within the 'screening' participant population. will be summed, and divided by the total number of colonoscopies in that participant population, to calculate MPP. MPP is usually expressed as a number to one decimal place.
Number of polyps per participant detected at colonoscopy in the 'symptomatic' participant population,as indicated by the Mean number of Polyps per Procedure (MPP)
The total number of polyps detected during colonoscopy for each participant within the 'symptomatic' participant population will be summed, and divided by the total number of colonoscopies in that participant population, to calculate MPP. MPP is usually expressed as a number to one decimal place.
Proportion of participants in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)
Whether or not at least one polyp is detected at colonoscopy will be determined for each participant. The number of colonoscopies where one or more polyps is detected will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.
Proportion of participants in the 'screening' participant population in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)
Whether or not at least one polyp is detected at colonoscopy will be determined for each participant within the 'screening' participant population. The number of colonoscopies where one or more polyps is identified will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.
Proportion of participants in the 'symptomatic' participant population in whom at least one polyp is detected at colonoscopy, as indicated by Polyp Detection Rate (PDR)
Whether or not at least one polyp is detected at colonoscopy will be determined for each participant within the 'symptomatic' participant population. The number of colonoscopies where one or more polyps is identified will be divided by the total number of colonoscopies in that participant population to calculate PDR, which is normally expressed as a percentage.
Polyp characteristics and location
The location, size, and morphology of the polyps identified (and histology if retrieved) in each study arm will be compared. This will also be analysed for both the screening and symptomatic participant populations in each study arm.
Sessile Serrated Polyp (SSP) detection rate
The number of colonoscopies in each study arm in which one or more SSPs is identified, divided by the total number of colonoscopies in each arm. This will also be analysed for both the screening and symptomatic participant populations in each study arm.
Colorectal Cancer (CRC) detection rate
The number of CRCs detected in each study arm divided by the total number of colonoscopies in each arm. This will include polyps removed and later found to cancerous on histology and lesions felt to be cancerous at the time of colonoscopy. This will also be analysed for both the screening and symptomatic participant populations in each study arm.
Advanced Adenoma (AA) detection rate
The number of AAs detected in each study arm divided by the total number of colonoscopies in each arm. This will also be analysed for both the screening and symptomatic participant populations in each study arm.
Caecal Intubation Rate
Caecal intubation rate (the proportion of colonoscopies in which the colonoscope reaches the furthest extent of the colon) will be compared between the study arms to assess for non-inferiority
Insertion time to caecum
Insertion time to caecum (time taken to reach the furthest point of the large bowel) will be compared between the study arms to assess for non-inferiority
Total Procedure Time
Total time required to perform the colonoscopy will be compared between the study arms to assess for non-inferiority
Total Withdrawal Time (in absence of polyps)
Total withdrawal time (time taken to remove the colonoscope from the furthest point of the colon) in the absence of any polyps will be compared between the study arms to assess for non-inferiority
Colonoscopist-assessed patient comfort score
Colonoscopist-assessed patient comfort scores will be compared between the study arms to assess for non-inferiority
Nurse-assessed patient comfort score
Nurse-assessed patient comfort scores will be compared between the study arms to assess for non-inferiority
Patient-Reported Experience
A validated Patient-Reported Experience Measure (Newcastle ENDOPREM) will be used to compare patient experience of colonoscopy between study arms
Patient-Reported Health-Related Quality of Life
The EuroQoL EQ-5D-5L (validated quality of life questionnaire) will be used to compare patient-reported health-related quality of life, between study arms
Projected future endoscopy workload
The need for further colonoscopy for each participant is determined by the findings at the index colonoscopy, according to national guidelines on polyp surveillance. This may differ between study arms if more polyps are identified in one arm.
MAP according to BCSP status of colonoscopist
Some colonoscopists partake in the national Bowel Cancer Screening Programme (BCSP) and some do not. MAP will be analysed by colonoscopist status within each study arm.
ADR according to BCSP status of colonoscopist
Some colonoscopists partake in the national Bowel Cancer Screening Programme (BCSP) and some do not. ADR will be analysed by colonoscopist status within each study arm.
Change in number of adenomas detected per colonoscopy, for each colonoscopist, over the course of the study, as indicated by MAP
MAP for the first 20 percent of participants will be compared to MAP for the last 20 percent of participants scoped by each participating colonoscopist, to assess for change over the course of the study.
Change in proportion of participants in whom at least one adenoma is detected during colonoscopy, for each colonoscopist, over the course of the study, as indicated by ADR.
ADR for the first 20 percent of participants will be compared to ADR for the last 20 percent of participants scoped by each participating colonoscopist, to assess for change over the course of the study.
Change in number of adenomas detected per participant, for each participating colonoscopist, from pre-study to intra-study (SC arm only)
MAP may vary from baseline, even in the control arm due to a contamination or learning effect; comparing baseline values to those during the study assesses for this effect.
Proportion of participants in whom at least one adenoma is detected during colonoscopy, for each participating colonoscopist, from pre-study to intra-study (SC arm only)
ADR may vary from baseline, even in the control arm due to a contamination or learning effect; comparing baseline values to those during the study assesses for this effect.