Abstract
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. Clinical Trial: The study is registered with clinicaltrials.org (NCT05154084).
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. Clinical Trial: The study is registered with clinicaltrials.org (NCT05154084).
| Original language | English |
|---|---|
| Number of pages | 38 |
| Journal | JMIR Research Protocols |
| DOIs | |
| Publication status | Accepted/In press - 22 Mar 2023 |
Bibliographical note
This study was supported byThe Rosetrees Trust Grant no CF1\100002
The Urology Foundation
Action Bladder Cancer UK
Karl Storz agreement
Photocure agreement
Medac Pharma agreement
The British Journal of Urology International Charity
None of the study funders had any academic input to the study design analysis or reporting.
