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.

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.

Work-Based Assessments in Higher General Surgical Training Program: A Mixed Methods Study Exploring Trainers' and Trainees' Views and Experiences.

Introduction In the United Kingdom, work-based assessments (WBAs) including procedure-based assessments (PBAs), case-based discussions (CBDs), clinical evaluation exercises (CEXs), and direct observation of procedural skills (DOPS) have been used in Higher General Surgical Training Program (HGSTP) since the introduction of Modernising Medical Careers. Although the Intercollegiate Surgical Curriculum Project states that they should be used for the formative development of trainees using feedback and reflection, there is no study to look at the perception of their usefulness and barriers in using them, particularly in HGSTP. The aim of this study is to investigate trainer's and trainee's perception of their usefulness, barriers in using them, and way forward for their improvement in HGSTP. Methods This was a mixed method study. In phase I, after ethics committee approval, an online survey was sent to 83 trainers and 104 trainees, with a response rate of 33 and 37%, respectively, using Online Surveys (formerly Bristol Online Survey) from July 2018 to December 2018. After analysis of this result, in phase II, semistructured interviews were conducted with five trainees and five trainers who had volunteered to take part from phase I. Thematic analysis was performed to develop overarching themes. Results For professional formative development, 15% of the trainers and 53% of the trainees felt that WBAs had a low value. Among 4 WBAs-CEX, CBD, PBA, and DOPS-PBA was thought to be the most useful WBA by 52% trainers and 74% trainees. More trainers than trainees felt that it was being used as a formative tool (33 vs. 16%). The total number of WBAs thought to be required was between 20 and 40 per year, with 46% of the trainers and 53% of the trainees preferring these numbers. The thematic analysis generated four themes with subthemes in each: theme 1, "factors affecting usefulness," including the mode of validation, trainer/trainee engagement, and time spent in validating; theme 2, "doubt on utility" due to doubt on validity and being used as a tick-box exercise; theme 3, "pitfalls/difficulties" due to lack of time to validate, late validation, e-mail rather than face-to-face validation, trainer and trainee behavior, variability in feedback given, and emphasis on number than quality; and theme 4, "improvement strategies." Conclusions The WBAs are not being used in a way they are supposed to be used. The perception of educational impact (Kirkpatrick levels 1 and 2) by trainers was more optimistic than by trainees. Improvements can be made by giving/finding more time, trainer training, more face-to-face validation, and better trainer trainee interactions.

Economic Implications of Providing Emergency Cholecystectomy for All Patients With Biliary Pathology: A Retrospective Analysis.

INTRODUCTION: This study assessed the safety and efficacy of acute laparoscopic cholecystectomy (ALC) in patients presenting with biliary pathology. The potential savings plus income generation for the hospital were calculated. METHODS: All patients undergoing emergency cholecystectomy were identified from computerized and hand-written theater records to ensure complete capture. Length of stay, procedure time, patient demographics, and postoperative complications were recorded. Tariffs for conservative versus acute management were calculated. Total admissions and readmissions with biliary pathology (acute cholecystitis, biliary colic, gallstone pancreatitis, and obstructive jaundice) over a 12-month period were recorded. RESULTS: Eighty-four patients undergoing ALC were identified. There was only 1 major complication (1 postoperative bleed managed laparoscopically). ALC for all admissions would result in savings of £ 695,918 over 12 months. The implementation of ALC for all patients would result in a small loss in revenue when compared with elective laparoscopic cholecystectomy (£ 15,495) provided that all operations could be accommodated on established operating lists. Implementing ALC on all appropriate biliary admissions could generate up to 3 cholecystectomies daily for a population base of 1 million. CONCLUSIONS: ALC is cost-effective and safe. It can be offered to all patients with biliary pathology provided they are fit enough for surgery.