Study protocol: transurethral REsection and Single instillation intravesical chemotherapy Evaluation in bladder Cancer Treatment (RESECT). A multi-centre international observational study with embedded cluster randomised trial of audit, feedback and education. (Preprint)

BACKGROUND Non-muscle invasive bladder cancer (NMIBC) accounts for 75% of bladder cancers. It is common and costly. Cost and detriment to patient outcomes and quality of life are driven by high recurrence rates and the need for regular invasive surveillance with frequent repeat treatments. There is evidence that the quality of the initial surgical procedure (Transurethral resection of bladder tumour (TURBT)) and timely administration of postoperative bladder chemotherapy significantly reduces cancer recurrence rates and improves outcomes such as cancer progression and mortality. There is some survey-based evidence that TURBT practice varies significantly across surgeons and sites1. There is evidence from clinical trials that NMIBC recurrence rate varies significantly between sites and that this cannot be accounted for by differences in patient, tumour, or adjuvant treatment factors, suggesting that how the surgery is performed may be a reason for the variation. OBJECTIVE This study primarily aims to determine if feedback of and education about surgical quality indicators can improve performance, and secondarily if this can reduce cancer recurrence rates. METHODS This study is an observational, international, multi-centre study with an embedded cluster randomised trial of audit, feedback, and education. Sites will be included if they perform TURBT for NMIBC. RESULTS The study has 4 co-primary outcomes which are 4 TURBT quality indicators: a surgical performance factor; an adjuvant treatment factor; and two documentation factors. A key secondary outcome is the early cancer recurrence rate. CONCLUSIONS Local and/or national ethical and institutional approvals or exemptions will be obtained at each participating site. The study results will be published in peer-reviewed journals and presented at national and international scientific congresses. CLINICALTRIAL The study is registered with clinicaltrials.org (NCT05154084).