En-bloc resection for bladder cancer

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2015
INTERVENTION: Participants are randomly allocated into the control group or the intervention group. The intervention group will undergo transurethral en‐bloc resection of the bladder tumor (TUEBR), and the control group will undergo conventional transurethral resection of the bladder tumor (TURB). For all patients: Follow up with cytology 4 weeks after operation. Cystoscopy and cytology 3, 6, 12, 18, 24, 36 months after operation, accordingly to our standard program. CONDITION: Newly diagnosed bladder cancer (ICD10: C67.9) ; Cancer ; Bladder cancer PRIMARY OUTCOME: Recurrence‐free survival (RFS). For primary endpoint (recurrence) the time from operation to biopsy date, confirming the recurrence, is measured. SECONDARY OUTCOME: 1. Interobserver variability of pathological stage. The histological slides from the primary operation are sent to 5 pathologists at the end of study. The tumorstage (Ta/T1/T2/Tis) is noted and the interobserver variability between groups is measured 3, 6, 12, 18, 24, 36 months after operation.; 2. Urinary cytology after resection (normal, atypic or malign) is measured 3, 6, 12, 18, 24, 36 months after operation. An additional follow up with cytology will be 4 weeks after operation INCLUSION CRITERIA: 1. Newly diagnosed, suspected bladder cancer 2. Age 18 years or over 3. 1‐3 bladder tumors 4. Tumor diameter between 1 and 3.5 cm
Epistemonikos ID: 0e69ef6ad096f288e56c5ff5cfb9f64a6e14b987
First added on: Aug 23, 2024