Polyp detection with colonoscopy assisted by the GI Genius artificial intelligence endoscopy module compared with standard colonoscopy in routine colonoscopy practice (COLO-DETECT): a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial.

BACKGROUND: Increased polyp detection during colonoscopy is associated with decreased post-colonoscopy colorectal cancer incidence and mortality. The COLO-DETECT trial aimed to assess the clinical effectiveness of the GI Genius intelligent endoscopy module for polyp detection, comparing colonoscopy assisted by GI Genius (computer-aided detection [CADe]-assisted colonoscopy) with standard colonoscopy in routine practice. METHODS: We did a multicentre, open-label, parallel-arm, pragmatic randomised controlled trial in 12 National Health Service (NHS) hospitals (ten NHS Trusts) in England, among adults (aged ≥18 years) undergoing planned colonoscopy for gastrointestinal symptoms or for surveillance due to personal or family history (ie, symptomatic indications), or colorectal cancer screening. Randomisation (1:1) to CADe-assisted colonoscopy or standard colonoscopy was done with a web-based dynamic adaptive algorithm, immediately before colonoscopy, with stratification by age group, sex, colonoscopy indication (screening or symptomatic), and NHS Trust. Recruiting staff, participants, and colonoscopists were unmasked to trial allocation; histopathologists, co-chief investigators, and trial statisticians were masked. CADe-assisted colonoscopy consisted of standard colonoscopy plus the GI Genius module active for at least the entire inspection phase of colonoscope withdrawal. The primary outcome was mean adenomas per procedure (total number of adenomas detected divided by total number of procedures); the key secondary outcome was adenoma detection rate (proportion of colonoscopies with at least one adenoma). Analysis was by intention to treat (ITT), with outcomes compared between groups by mixed-effects regression modelling, in which effect estimates were adjusted for randomisation stratification variables. Data were imputed for outcome measures with more than 5% missing values. All participants who underwent colonoscopy were assessed for safety. The trial is registered on ISRCTN (ISRCTN10451355) and ClinicalTrials.gov (NCT04723758), and is complete. FINDINGS: Between March 29, 2021, and April 6, 2023, 2032 participants (1132 [55·7%] male, 900 [44·3%] female; mean age 62·4 years [SD 10·8]) were recruited and randomly assigned: 1015 to CADe-assisted colonoscopy and 1017 to standard colonoscopy. 1231 (60·6%) participants were undergoing screening and 801 (39·4%) had symptomatic indications. Mean adenomas per procedure was 1·56 (SD 2·82; n=1001 participants with available data) in the CADe-assisted colonoscopy group versus 1·21 (1·91; n=1009) in the standard colonoscopy group, representing an adjusted mean difference of 0·36 (95% CI 0·14-0·57; adjusted incidence rate ratio 1·30 [95% CI 1·15-1·47], p<0·0001). Adenomas were detected in 555 (56·6%) of 980 participants in the CADe-assisted colonoscopy group versus 477 (48·4%) of 986 in the standard colonoscopy group, representing a proportion difference of 8·3% (95% CI 3·9-12·7; adjusted odds ratio 1·47 [95% CI 1·21-1·78], p<0·0001). Numbers of adverse events were similar between the CADe-assisted colonoscopy and standard colonoscopy groups (adverse events: 25 vs 19; serious adverse events: four vs six), and no adverse events in the CADe-assisted colonoscopy group were deemed to be related to GI Genius use on independent review. INTERPRETATION: Results of the COLO-DETECT trial support the use of GI Genius to increase detection of premalignant colorectal polyps in routine colonoscopy practice. FUNDING: Medtronic.

'I Do It All Alone': The Burdens and Benefits of Being Diagnosed With, and Treated for, Colorectal Cancer During the Covid-19 Pandemic.

INTRODUCTION: The Covid-19 pandemic dramatically altered the way cancer care services were accessed and delivered, including for colorectal cancer (CRC). In the United Kingdom, patients were discouraged from presenting in primary care, many consultations took place remotely, investigative procedures and screening programmes were temporarily suspended, and fewer operations and treatments were delivered. People had to face the practical consequences of having cancer during a pandemic and navigate never before seen pathways, often alone. We examined the experience of being diagnosed and treated for CRC during the pandemic, and the implications of this on people's cancer journeys. METHODS: Semi-structured interviews were undertaken with people diagnosed with CRC during the Covid-19 pandemic (January 2020-May 2021), in the North East of England. An iterative topic guide was used during interviews, which took place remotely (telephone or Zoom), were audio recorded, pseudo-anonymised and transcribed. Initial transcripts were independently coded by two researchers, and a code 'bank' developed for application across transcripts. Development of themes and overarching analytical constructs was undertaken collaboratively by the research team. RESULTS: Interviews were conducted with 19 participants, analysed and four key themes identified: (1) The relative threats of Covid-19 and Cancer were not comparable, with cancer seen as posing a far greater risk than Covid-19; (2) Remote consultations were problematic, affecting patients' abilities to build rapport and trust with clinicians, assess nonverbal communication, and feel able to disclose, comprehend and retain information; (3) Stoma follow-up care was seen to be lacking, with long wait times for stoma reversal experienced by some; Finally, (4) Being alone during consultations negatively impacted some peoples' abilities to absorb information, and left them without the support of loved ones at an emotionally vulnerable time. However, some participants preferred being alone at certain points in their pathways, including receiving a diagnosis, and most frequently when receiving in-patient treatment. CONCLUSION: Being alone brought unexpected benefits, absolving people from undertaking emotions work for others, and instead focus on their recovery, however, remote consultations negatively impacted patients' experiences. This study highlights the complex benefits and burdens of pandemic-located cancer journeys, including how these shifted at different points across cancer pathways. PATIENT OR PUBLIC CONTRIBUTION: Lorraine Angell, a cancer survivor, has been central to this study from idea conception, contributing to: development of study focus and design; securing funding; production of patient-facing materials; development of interview topic guides; analysis and interpretation of data; and drafting of key findings and manuscripts.

Patient experiences of Cytosponge: a qualitative study.

Objective: Cytosponge is a novel technology for oesophageal pathology diagnosis. Uses include diagnosis of Barrett's oesophagus and as a triage tool to prioritise upper gastrointestinal endoscopy. Patient experience is a key component of quality care. Previous work has developed endoscopy patient-reported experience measures. An appropriate tool to measure patient experience of Cytosponge is required. The aim of this work was to describe the patient experience of Cytosponge. Design/Method: Individuals aged 18 years or over, who had undergone Cytosponge from September 2020 to March 2021, were invited to participate in a semi-structured interview. Interviews were audio-recorded, transcribed verbatim and anonymised. Thematic analysis was undertaken. Themes were organised into two overarching areas relating to patient experiences and patient perceptions of the test. Results: 19 patients underwent interview (aged 37-80 years, 13 male). In terms of patient experiences of Cytosponge, five themes were identified: emotional reaction; expectations; environment and physical process; sensory experience; communication and information. All themes were present across all procedural phases, aside from sensory experience which was only present during the test. With regard to perception of the test, two major themes were identified: test novelty (encompassing patient awareness of the test and reaction to the new test) and trusting the test results. Conclusion: Patients must remain central to novel technologies such as Cytosponge. Measuring patient experience is essential to achieve that. This study demonstrates five major themes which describe the patient experience of this procedure. These have been used to adapt the Newcastle ENDOPREM for use in Cytosponge.

The effect of aspirin and eicosapentaenoic acid on urinary biomarkers of prostaglandin E2 synthesis and platelet activation in participants of the seAFOod polyp prevention trial.

Urinary prostaglandin (PG) E metabolite (PGE-M) and 11-dehydro (d)-thromboxane (TX) B2 are biomarkers of cyclooxygenase-dependent prostanoid synthesis. We investigated (1) the effect of aspirin 300 mg daily and eicosapentaenoic acid (EPA) 2000 mg daily, alone and in combination, on urinary biomarker levels and, (2) whether urinary biomarker levels predicted colorectal polyp risk, during participation in the seAFOod polyp prevention trial. Urinary PGE-M and 11-d-TXB2 were measured by liquid chromatography-tandem mass spectrometry. The relationship between urinary biomarker levels and colorectal polyp outcomes was investigated using negative binomial (polyp number) and logistic (% with one or more polyps) regression models. Despite wide temporal variability in PGE-M and 11-d-TXB2 levels within individuals, both aspirin and, to a lesser extent, EPA decreased levels of both biomarkers (74% [P ≤ .001] and 8% [P ≤ .05] reduction in median 11-d-TXB2 values, respectively). In the placebo group, a high (quartile [Q] 2-4) baseline 11-d-TXB2 level predicted increased polyp number (incidence rate ratio [IRR] [95% CI] 2.26 [1.11,4.58]) and risk (odds ratio [95% CI] 3.56 [1.09,11.63]). A low (Q1) on-treatment 11-d-TXB2 level predicted reduced colorectal polyp number compared to placebo (IRR 0.34 [0.12,0.93] for combination aspirin and EPA treatment) compared to high on-treatment 11-d-TXB2 values (0.61 [0.34,1.11]). Aspirin and EPA both inhibit PGE-M and 11-d-TXB2 synthesis in keeping with shared in vivo cyclooxygenase inhibition. Colorectal polyp risk and treatment response prediction by 11-d-TXB2 is consistent with a role for platelet activation during early colorectal carcinogenesis. The use of urinary 11-d-TXB2 measurement for a precision approach to colorectal cancer risk prediction and chemoprevention requires prospective evaluation.

The performance of FIT-based and other risk prediction models for colorectal neoplasia in symptomatic patients: a systematic review.

Background: Colorectal cancer (CRC) incidence and mortality are increasing internationally. Endoscopy services are under significant pressure with many overwhelmed. Faecal immunochemical testing (FIT) has been advocated to identify a high-risk population of symptomatic patients requiring definitive investigation by colonoscopy. Combining FIT with other factors in a risk prediction model could further improve performance in identifying those requiring investigation most urgently. We systematically reviewed performance of models predicting risk of CRC and/or advanced colorectal polyps (ACP) in symptomatic patients, with a particular focus on those models including FIT. Methods: The review protocol was published on PROSPERO (CRD42022314710). Searches were conducted from database inception to April 2023 in MEDLINE, EMBASE, Cochrane libraries, SCOPUS and CINAHL. Risk of bias of each study was assessed using The Prediction study Risk Of Bias Assessment Tool. A narrative synthesis based on the guidelines for Synthesis Without Meta-Analysis was performed due to study heterogeneity. Findings: We included 62 studies; 23 included FIT (n = 22) or guaiac Faecal Occult Blood Testing (n = 1) combined with one or more other variables. Twenty-one studies were conducted solely in primary care. Generally, prediction models including FIT consistently had good discriminatory ability for CRC/ACP (i.e. AUC >0.8) and performed better than models without FIT although some models without FIT also performed well. However, many studies did not present calibration and internal and external validation were limited. Two studies were rated as low risk of bias; neither model included FIT. Interpretation: Risk prediction models, including and not including FIT, show promise for identifying those most at risk of colorectal neoplasia. Substantial limitations in evidence remain, including heterogeneity, high risk of bias, and lack of external validation. Further evaluation in studies adhering to gold standard methodology, in appropriate populations, is required before widespread adoption in clinical practice. Funding: National Institute for Health and Care Research (NIHR) [Health Technology Assessment Programme (HTA) Programme (Project number 133852).

Polymorphisms in Cyclooxygenase, Lipoxygenase, and TP53 Genes Predict Colorectal Polyp Risk Reduction by Aspirin in the seAFOod Polyp Prevention Trial.

Aspirin and eicosapentaenoic acid (EPA) reduce colorectal adenomatous polyp risk and affect synthesis of oxylipins including prostaglandin E2. We investigated whether 35 SNPs in oxylipin metabolism genes such as cyclooxygenase (PTGS) and lipoxygenase (ALOX), as well as 7 SNPs already associated with colorectal cancer risk reduction by aspirin (e.g., TP53; rs104522), modified the effects of aspirin and EPA on colorectal polyp recurrence in the randomized 2 × 2 factorial seAFOod trial. Treatment effects were reported as the incidence rate ratio (IRR) and 95% confidence interval (CI) by stratifying negative binomial and Poisson regression analyses of colorectal polyp risk on SNP genotype. Statistical significance was reported with adjustment for the false discovery rate as the P and q value. 542 (of 707) trial participants had both genotype and colonoscopy outcome data. Reduction in colorectal polyp risk in aspirin users compared with nonaspirin users was restricted to rs4837960 (PTGS1) common homozygotes [IRR, 0.69; 95% confidence interval (CI), 0.53-0.90); q = 0.06], rs2745557 (PTGS2) compound heterozygote-rare homozygotes [IRR, 0.60 (0.41-0.88); q = 0.06], rs7090328 (ALOX5) rare homozygotes [IRR 0.27 (0.11-0.64); q = 0.05], rs2073438 (ALOX12) common homozygotes [IRR, 0.57 (0.41-0.80); q = 0.05], and rs104522 (TP53) rare homozygotes [IRR, 0.37 (0.17-0.79); q = 0.06]. No modification of colorectal polyp risk in EPA users was observed. In conclusion, genetic variants relevant to the proposed mechanism of action on oxylipins are associated with differential colorectal polyp risk reduction by aspirin in individuals who develop multiple colorectal polyps. SNP genotypes should be considered during development of personalized, predictive models of colorectal cancer chemoprevention by aspirin. PREVENTION RELEVANCE: Single-nucleotide polymorphisms in genes controlling lipid mediator signaling may modify the colorectal polyp prevention activity of aspirin. Further investigation is required to determine whether testing for genetic variants can be used to target cancer chemoprevention by aspirin to those who will benefit most.

A Systematic Review of Population-Based Studies of Chronic Bowel Symptoms in Cancer Survivors following Pelvic Radiotherapy.

Pelvic radiotherapy can damage surrounding tissue and organs, causing chronic conditions including bowel symptoms. We systematically identified quantitative, population-based studies of patient-reported bowel symptoms following pelvic radiotherapy to synthesize evidence of symptom type, prevalence, and severity. Medline, CINAHL, EMBASE, and PsychINFO were searched from inception to September 2022. Following independent screening of titles, abstracts, and full-texts, population and study characteristics and symptom findings were extracted, and narrative synthesis was conducted. In total, 45 papers (prostate, n = 39; gynecological, n = 6) reporting 19 datasets were included. Studies were methodologically heterogeneous. Most frequently assessed was bowel function ('score', 26 papers, 'bother', 19 papers). Also assessed was urgency, diarrhea, bleeding, incontinence, abdominal pain, painful hemorrhoids, rectal wetness, constipation, mucous discharge, frequency, and gas. Prevalence ranged from 1% (bleeding) to 59% (anal bleeding for >12 months at any time since start of treatment). In total, 10 papers compared radiotherapy with non-cancer comparators and 24 with non-radiotherapy cancer patient groups. Symptom prevalence/severity was greater/worse in radiotherapy groups and symptoms more common/worse post-radiotherapy than pre-diagnosis/treatment. Symptom prevalence varied between studies and symptoms. This review confirms that many people experience chronic bowel symptoms following pelvic radiotherapy. Greater methodological consistency, and investigation of less-well-studied survivor populations, could better inform the provision of services and support.

Quality in colonoscopy: time to ensure national standards are implemented?

Background: High-quality colonoscopy is crucial to ensure complete mucosal visualisation and to maximise detection of pathology. Previous audits showing variable quality have prompted national and international colonoscopy improvement programmes, including the development of quality assurance standards and key performance indicators (KPIs). The most widely used marker of mucosal visualisation is the adenoma detection rate (ADR), however, histological confirmation is required to calculate this. We explored the relationship between core colonoscopy KPIs. Methods: Data were collected from colonoscopists in eight hospitals in North East England over a 6-month period, as part of a quality improvement study. Procedural information was collected including number of colonoscopies, caecal intubation rate (CIR), ADR and polyp detection rate (PDR). Associations between KPIs and colonoscopy performance were analysed. Results: 9265 colonoscopies performed by 118 endoscopists were included. Mean ADR and PDR per endoscopist were 16.6% (range 0-36.3, SD 7.4) and 27.2% (range 0-57.5, SD 9.3), respectively. Mean number of colonoscopies conducted in 6 months was 78.5 (range 4-334, SD 61). Mean CIR was 91.2% (range 55.5-100, SD 6.6). Total number of colonoscopies and ADR>15% were significantly associated (p=0.04). Undertaking fewer colonoscopies and using hyoscine butylbromide less frequently was significantly associated with ADR<15%. CIR, endoscopist grade, % male patients, mean patient age and CIR were not significantly related to ADR<15%. In adjusted analyses, factors which affected ADR were PDR and mean patient age. Conclusion: Colonoscopists who perform fewer than the nationally stipulated minimum of 100 procedures per year had significantly lower ADRs. This study demonstrates that PDR can be used as a marker of ADR; providing age is also considered.

Colorectal polyp outcomes after participation in the seAFOod polyp prevention trial: Evidence of rebound elevated colorectal polyp risk after short-term aspirin use.

BACKGROUND: The seAFOod polyp prevention trial was a randomised, placebo-controlled, 2 × 2 factorial trial of aspirin 300 mg and eicosapentaenoic acid (EPA) 2000 mg daily in individuals who had a screening colonoscopy in the English Bowel Cancer Screening Programme (BCSP). Aspirin treatment was associated with a 20% reduction in colorectal polyp number at BCSP surveillance colonoscopy 12 months later. It is unclear what happens to colorectal polyp risk after short-term aspirin use. AIM: To investigate colorectal polyp risk according to the original trial treatment allocation, up to 6 years after trial participation. METHODS: All seAFOod trial participants were scheduled for further BCSP surveillance and provided informed consent for the collection of colonoscopy outcomes. We linked BCSP colonoscopy data to trial outcomes data. RESULTS: In total, 507 individuals underwent one or more colonoscopies after trial participation. Individuals grouped by treatment allocation were well matched for clinical characteristics, follow-up duration and number of surveillance colonoscopies. The polyp detection rate (PDR; the number of individuals who had ≥1 colorectal polyp detected) after randomization to placebo aspirin was 71.1%. The PDR was 80.1% for individuals who had received aspirin (odds ratio [OR] 1.13 [95% confidence interval 1.02, 1.24]; p = 0.02). There was no difference in colorectal polyp outcomes between individuals who had been allocated to EPA compared with its placebo (OR for PDR 1.00 [0.91, 1.10]; p = 0.92). CONCLUSION: Individuals who received aspirin in the seAFOod trial demonstrated increased colorectal polyp risk during post-trial surveillance. Rebound elevated neoplastic risk after short-term aspirin use has important implications for aspirin cessation driven by age-related bleeding risk. ISRCTN05926847.

High quality colonoscopy: using textbook process as a composite quality measure.

BACKGROUND : High quality colonoscopy is fundamental to good patient outcomes. "Textbook outcome" has proven to be a feasible multidimensional measure for quality assurance between surgical centers. In this study, we sought to establish the "textbook process" (TP) as a new composite measure for the optimal colonoscopy process and assessed how frequently TP was attained in clinical practice and the variation in TP between endoscopists. METHODS : To reach consensus on the definition of TP, international expert endoscopists completed a modified Delphi consensus process. The achievement of TP was then applied to clinical practice. Prospectively collected data in two endoscopy services were retrospectively evaluated. Data on colonoscopies performed for symptoms or surveillance between 1 January 2018 and 1 August 2021 were analyzed. RESULTS : The Delphi consensus process was completed by 20 of 27 invited experts (74.1 %). TP was defined as a colonoscopy fulfilling the following items: explicit colonoscopy indication; successful cecal intubation; adequate bowel preparation; adequate withdrawal time; acceptable patient comfort score; provision of post-polypectomy surveillance recommendations in line with guidelines; and the absence of the use of reversal agents, early adverse events, readmission, and mortality. In the two endoscopy services studied, TP was achieved in 5962/8227 colonoscopies (72.5 %). Of 48 endoscopists performing colonoscopy, attainment of TP varied significantly, ranging per endoscopist from 41.0 % to 89.1 %. CONCLUSION : This study proposes a new composite measure for colonoscopy, namely "textbook process." TP gives a comprehensive summary of performance and demonstrates significant variation between endoscopists, illustrating the potential benefit of TP as a measure in future quality assessment programs.

Barriers to colonoscopy in UK colorectal cancer screening programmes: Qualitative interviews with ethnic minority groups.

OBJECTIVE: People from ethnic minority backgrounds are less likely to attend colonoscopy, following faecal immunochemical test screening, and are more likely to be diagnosed with colorectal cancer at an advanced stage as a result. The aim of this research was to explore the barriers and facilitators to attending colonoscopy, perceived by ethnic minority groups living in the United Kingdom. METHODS: Semi-structured online and telephone interviews were conducted with thirty men and women of Black-African (n = 5), Black-Caribbean (n = 5), South Asian (n = 10) and White British (n = 10) descent. Participants were eligible for screening, but had not necessarily been invited for colonoscopy. All interviews were conducted in the participant's first language and were assessed using Framework-analysis, in line with a conceptual framework developed from previous interviews with healthcare professionals. RESULTS: Five thematic groups of barriers and facilitators were developed: 'Locus of control', 'Cultural attitudes and beliefs', 'Individual beliefs, knowledge and personal experiences with colonoscopy and cancer', 'Reliance on family and friends' and 'Health concerns'. Differences were observed, between ethnic groups, for: 'Locus of control', 'Cultural attitudes and beliefs' and 'Reliance on family and friends'. Black and South Asian participants frequently described the decision to attend colonoscopy as lying with 'God' (Muslims, specifically), 'the doctor', or 'family' (Locus of control). Black and South Asian participants also reported relying on friends and family for 'language, transport and emotional support' (Reliance on family and friends). Black-African participants, specifically, described cancer as 'socially taboo' (Cultural attitudes and beliefs). CONCLUSIONS: The results highlight several targets for culturally-tailored interventions to make colonoscopy more equitable.

The effect of the endoscopic device Endocuff™/Endocuff vision™ on quality standards in colonoscopy: A systematic review and meta-analysis of randomized trials.

AIM: The adenoma detection rate (ADR) is an important quality measure, with a high ADR reflecting high-quality colonoscopy. This systematic review and meta-analysis aimed to assess the effects of Endocuff™/Endocuff Vision™-assisted colonoscopy (EAC) versus standard colonoscopy (SC) on ADR and other clinical, patient and resource-use outcomes. METHOD: MEDLINE, EMBASE, Web of Science, Scopus and the Cochrane Central Register of Controlled Trials were searched for full papers reporting randomized studies comparing EAC with SC. The primary outcome was ADR. Secondary outcomes comprised key polyp/adenoma detection, procedure-related, patient-related and health economic measures. Random effects meta-analyses provided pooled estimates of outcomes [risk ratio (RR) or mean difference (MD), with 95% confidence intervals (CI)]. RESULTS: Twelve parallel-group randomized controlled trials (RCTs) and three crossover RCTs with data on 9140 patients were included. EAC significantly increased the ADR (RR 1.18, 95% CI 1.09-1.29), mean adenomas per procedure (MAP) (MD 0.19, 95% CI 0.06-0.33), polyp detection rate (PDR) (RR 1.20, 95% CI 1.10-1.30) and mean polyps per procedure (MPP) (MD 0.39, 95% CI 0.14-0.63) versus SC. EAC significantly increased segmental PDR versus SC in the sigmoid (RR 2.02, 95% CI 1.64-2.49), transverse (RR 1.63, 95% CI 1.09-2.42), ascending (RR 1.74, 95% CI 1.26-2.41) and caecal segments (RR 1.91, 95% CI 1.29-2.82). Procedure-related variables did not differ between arms. There were insufficient data for meta-analysis of health economic or patient-centred outcomes. CONCLUSIONS: EAC increased ADR, MAP, PDR and MPP versus SC without detrimental effects on procedure measures. Cost-effectiveness and patient experience data are lacking and would be valuable to inform practice recommendations.

Trial protocol for COLO-DETECT: A randomized controlled trial of lesion detection comparing colonoscopy assisted by the GI Genius™ artificial intelligence endoscopy module with standard colonoscopy.

AIM: Colorectal cancer is the second commonest cause of cancer death worldwide. Colonoscopy plays a key role in the control of colorectal cancer and, in that regard, maximizing detection (and removal) of pre-cancerous adenomas at colonoscopy is imperative. GI Genius™ (Medtronic Ltd) is a computer-aided detection system that integrates with existing endoscopy systems and improves adenoma detection during colonoscopy. COLO-DETECT aims to assess the clinical and cost effectiveness of GI Genius™ in UK routine colonoscopy practice. METHODS AND ANALYSIS: Participants will be recruited from patients attending for colonoscopy at National Health Service sites in England, for clinical symptoms, surveillance or within the national Bowel Cancer Screening Programme. Randomization will involve a 1:1 allocation ratio (GI Genius™-assisted colonoscopy:standard colonoscopy) and will be stratified by age category (<60 years, 60-<74 years, ≥74 years), sex, hospital site and indication for colonoscopy. Demographic data, procedural data, histology and post-procedure patient experience and quality of life will be recorded. COLO-DETECT is designed and powered to detect clinically meaningful differences in mean adenomas per procedure and adenoma detection rate between GI Genius™-assisted colonoscopy and standard colonoscopy groups. The study will close when 1828 participants have had a complete colonoscopy. An economic evaluation will be conducted from the perspective of the National Health Service. A patient and public representative is contributing to all stages of the trial. Registered at ClinicalTrials.gov (NCT04723758) and ISRCTN (10451355). WHAT WILL THIS TRIAL ADD TO THE LITERATURE?: COLO-DETECT will be the first multi-centre randomized controlled trial evaluating GI Genius™ in real world colonoscopy practice and will, uniquely, evaluate both clinical and cost effectiveness.