Study titel: En Bloc transurethral resection of non-muscle invasive bladder tumours
Aim: The aim of this study is to compare the surgical method of En Bloc-resection to the conventional TURB of NMIBC in terms of complete removal of tumour, specimen quality, and pathological certainty.
Methods: The project is a multicentre randomised clinical trial comparing En Bloc-resection (EBR) to conventional TURB (cTURB). Patients with primary NMIBC tumours with diameter ≥1cm and <6cm are randomised to either the intervention group, undergoing EBR, or the control group, undergoing cTURB.
Sample size will be 220 patients in total, 110 in each group.
Ultimately, a central pathology revision of all specimens is performed to investigate the pathological outcome of EBR compared to cTURB. The primary endpoint will be number of patients with an unaltered T-stage at pathology revision compared to the initial resection.
In addition, patient reported outcome (PRO) will be collected in form of validated questionnaires regarding bladder symptoms and quality of life at baseline, 2 week post-op, and at 4- and 12-month follow-up.
· Primary, papillary, non-solid bladder tumour visualized by flexible cystoscopy
· Tumour diameter >1 cm estimated by an experienced urologist or, when possible, on CT scan
· Age ≥ 18 years
· Ability to understand the participant information orally and in writing
· Signed consent form
· Clinically suspected muscle invasive bladder tumour (invasion visible on CT or solid tumour without papillary elements seen at flexible cystoscopy)
· Tumour located in a bladder diverticulum
· Investigating physician concludes that EBR is not technically possible
Nielsen NK, Jakobsen JK, Kingo PS, et al. Potential candidates for en bloc resection among patients with primary and recurrent bladder tumours. Scand J Urol. 2021;55(5):366-71
Ninna Kjær Nielsen