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BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial
  1. Colin J Rees1,
  2. Andrew Brand2,
  3. Wee Sing Ngu3,
  4. Clive Stokes4,
  5. Zoe Hoare2,
  6. Nicola Totton2,
  7. Pradeep Bhandari5,
  8. Linda Sharp6,
  9. Alexandra Bastable2,
  10. Matthew D Rutter7,8,
  11. Ajay Mark Verma9,
  12. Thomas J Lee10,
  13. Martin Walls3
  14. The B-ADENOMA trial group comprises
    1. 1 Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK
    2. 2 North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, Gwynedd, UK
    3. 3 Gastroenterology, South Tyneside NHS Foundation Trust, South Shields, South Tyneside, UK
    4. 4 Research, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, Gloucestershire, UK
    5. 5 Gastroenterology, Portsmouth Hospitals NHS Trust, Portsmouth, Portsmouth, UK
    6. 6 Institute of Health and Society, Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK
    7. 7 Gastroenterology, North Tees and Hartlepool NHS Foundation Trust, Hartlepool, Hartlepool, UK
    8. 8 Medicine, University of Durham, Durham, Durham, UK
    9. 9 Gastroenterology, Kettering General Hospital NHS Foundation Trust, Kettering, Northamptonshire, UK
    10. 10 Gastroenterology Research, Northumbria Healthcare NHS Foundation Trust, North Shields, UK
    1. Correspondence to Professor Colin J Rees, Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne NE1 7RU, UK; Colin.Rees{at}newcastle.ac.uk

    Abstract

    Objectives Adenoma detection rate (ADR) is an important quality marker at lower GI endoscopy. Higher ADRs are associated with lower postcolonoscopy colorectal cancer rates. The English flexible sigmoidoscopy (FS) screening programme (BowelScope), offers a one-off FS to individuals aged 55 years. However, variation in ADR exists. Large studies have demonstrated improved ADR using Endocuff Vision (EV) within colonoscopy screening, but there are no studies within FS. We sought to test the effect of EV on ADR in a national FS screening population.

    Design BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities was a multicentre, randomised controlled trial involving 16 English BowelScope screening centres. Individuals were randomised to Endocuff Vision-assisted BowelScope (EAB) or Standard BowelScope (SB). ADR, polyp detection rate (PDR), mean adenomas per procedure (MAP), polyp characteristics and location, participant experience, procedural time and adverse events were measured. Comparison of ADR within the trial with national BowelScope ADR was also undertaken.

    Results 3222 participants were randomised (53% male) to receive EAB (n=1610) or SB (n=1612). Baseline demographics were comparable between arms. ADR in the EAB arm was 13.3% and that in the SB arm was 12.2% (p=0.353). No statistically significant differences were found in PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics. ADR in the SB control arm was 3.1% higher than the national ADR.

    Conclusion EV did not improve BowelScope ADR when compared with SB. ADR in both arms was higher than the national ADR. Where detection rates are already high, EV is unable to improve detection further.

    Trial registration numbers NCT03072472, ISRCTN30005319 and CPMS ID 33224.

    • colonic adenomas
    • gastrointesinal endoscopy
    • colorectal adenomas
    • colonic polyps
    • colorectal cancer screening
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    Footnotes

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    • Correction notice This article has been corrected since it published Online First. The arrow alignment in figure 2 has been corrected.

    • Collaborators The BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities or B-ADENOMA trial group comprises Professor Colin J Rees, Professor Matthew Rutter, Dr Ajay M Verma, Dr Tom Lee, Dr Jonathan Landy, Dr Andrew Veitch, Dr Andrew Higham, Dr Rodger Prudham, Dr Simon Hellier, Dr James Schutt, Ms Clare Westwood, Dr Ana Wilson, Dr James East, Dr Stuart Riley, Dr George Lipscomb, Dr Sara Koo and Dr Laura Neilson.

    • Contributors CJR: designed the study, contributed to the running of study, recruited patients to the study, analysed results, and reviewed and contributed to the writing of manuscript; AB, WSN and ZH: contributed to the study design, reviewed the analysis, and reviewed and contributed to the writing of the manuscript; CS: managed trial sites and reviewed and contributed to the writing of the manuscript; NT: contributed to the study design, data custodian during the trial conduct, reviewed the analysis, and reviewed and contributed to the writing of the manuscript; PB, MDR, AMV and TJL: contributed to running of the study, recruited patients to the study, analysed the results, and reviewed and contributed to the writing of the manuscript; LS: analysed the results, reviewed and contributed to the writing of the manuscript; AB: contributed to running of the study, assisted in the analysis of the results, and reviewed and contributed to the writing of the manuscript; MW: contributed to the study design, ran the study, recruited patients to the study, analysed the results, and reviewed contributed to the writing of the manuscript.

    • Funding BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalitiesor B-ADENOMA was an investigator-led study funded by ARC Medical and was adapted onto the English National Institute for Health Research Portfolio.

    • Disclaimer The funder had no role in study design, data collection, data analysis, data interpretation, or writing of this manuscript. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit.

    • Competing interests CJR has received grant funding from ARC medical, Norgine and Olympus medical. He was an expert witness for ARC Medical. PB has received grant funding from Norgine.

    • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

    • Patient consent for publication Not required.

    • Ethics approval A favourable ethical opinion was received from UK West Midlands–Solihull Research Ethics Committee.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information. All data relevant to the study are included in the article or uploaded as supplementary information.

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