BACKGROUND: There has been increasing interest in en bloc resection of bladder tumour (ERBT) as an oncologically noninferior alternative to transurethral resection of bladder tumour (TURBT) with fewer complications and better histology specimens. However, there is a lack of robust randomised controlled trial (RCT) data for making recommendations. OBJECTIVE: We aimed to develop a consensus statement to standardise various aspects of ERBT for clinical practice and to guide future research. DESIGN, SETTING, AND PARTICIPANTS: We developed the consensus statement on ERBT using a modified Delphi method. First, two systematic reviews were performed to investigate the clinical effectiveness of ERBT versus TURBT (effectiveness review) and to identify areas of uncertainty in ERBT (uncertainties review). Next, 200 health care professionals (urologists, oncologists, and pathologists) with experience in ERBT were invited to complete a two-round Delphi survey. Finally, a 16-member consensus panel meeting was held to review, discuss, and re-vote on the statements as appropriate. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Meta-analyses were performed for RCT data in the effectiveness review. Consensus statements were developed from the uncertainties review. Consensus was defined as follows: (1) ≥70% scoring a statement 7-9 and ≤15% scoring the statement 1-3 (consensus agree), or (2) ≥70% scoring a statement 1-3 and ≤15% scoring the statement 7-9 (consensus disagree). RESULTS AND LIMITATIONS: A total of 10 RCTs were identified upon systematic review. ERBT had a shorter irrigation time (mean difference -7.24 h, 95% confidence interval [CI] -9.29 to -5.20, I2 = 85%, p < 0.001) and a lower rate of bladder perforation (risk ratio 0.30, 95% CI 0.11-0.83, I2 = 1%, p = 0.02) than TURBT, both with moderate certainty of evidence. There were no significant differences in recurrences at 0-12, 13-24, or 25-36 mo (all very low certainty of evidence). A total of 103 statements were developed, of which 99 reached a consensus. A summary of statements is as follows: ERBT should always be considered for treating non-muscle-invasive bladder cancer; ERBT should be considered feasible even for bladder tumours larger than 3 cm; number and location of bladder tumours are not major limitations in performing ERBT; the planned circumferential margin should be at least 5 mm from any visible bladder tumour; after ERBT, additional biopsy of the tumour edge or tumour base should not be performed routinely; for the ERBT specimen, T1 substage, and circumferential and deep resection margins must be assessed; it is safe to give a single dose of immediate intravesical chemotherapy, perform second-look transurethral resection, and give intravesical bacillus Calmette-Guérin (BCG) therapy after ERBT; and in studies of ERBT, both per-patient and -tumour analysis should be performed for different outcomes as appropriate. Important outcomes for future ERBT studies were also identified. A limitation is that as consensus statements are brief, concise and binary in nature, areas of uncertainty that are complex in nature may not be addressed adequately. CONCLUSIONS: We have provided the most comprehensive review of the evidence base to date using a meta-analysis where appropriate and applying the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology, and mobilised the international urology community to develop a consensus statement on ERBT using transparent and robust methods. The consensus statement will provide interim guidance for health care professionals who practice ERBT and inform researchers regarding ERBT-related studies in the future. PATIENT SUMMARY: En bloc resection of bladder tumour (ERBT) is a surgical technique aiming to resect a bladder tumour in one piece. We included an international panel of experts to agree on the best practice of ERBT, and this will provide guidance to clinicians and researchers in the future.

Academic Urology Unit University of Aberdeen Aberdeen UK

Department of Anatomical and Cellular Pathology The Chinese University of Hong Kong Hong Kong China

Department of Clinical Oncology The Chinese University of Hong Kong Hong Kong China

Department of Medicine McMaster University Hamilton Canada

Department of Urology 2nd Faculty of Medicine Hospital Motol Charles University Prague Czech Republic

Department of Urology Fundacion Puigvert Universitat Autonoma de Barcelona Barcelona Spain

Department of Urology Hanover Medical School Hanover Germany

Department of Urology Institut Universitaire du Cancer Toulouse France

Department of Urology Jikei University School of Medicine Kashiwa Hospital Kashiwa Japan

Department of Urology National University Hospital National University Health System Singapore

Department of Urology Royal Surrey County Hospital Guildford Surrey UK

Department of Urology Singapore General Hospital Singapore

Department of Urology Spital Thurgau AG Frauenfeld Switzerland

Department of Urology The 1st Affiliated Hospital of Fujian Medical University Fuzhou Fujian China

Department of Urology University Hospital Schleswig Holstein Campus Luebeck Luebeck Germany

Li Ping Medical Library The Chinese University of Hong Kong Hong Kong China

Medical University of Vienna Vienna Austria

New Territories East Cluster Bladder Cancer Support Group Hong Kong China

S H Ho Urology Centre Department of Surgery The Chinese University of Hong Kong Hong Kong China

School of Medicine Faculty of Medicine and Health University of Leeds Leeds UK

Urology Department Kaohsiung Municipal Ta Tung Hospital Kaohsiung Taiwan

Urology Service Department of Surgery Sengkang General Hospital Sengkang Singapore

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