En-bloc resection for bladder cancer

Not Applicable

• Conditions: ewly diagnosed bladder cancer (ICD10: C67.9); Cancer; Bladder cancer

• Registration Number: ISRCTN16837985
• Lead Sponsor: Skåne University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-23
• Study Completion: 2022-05-30
• Last Update Posted: 4 July 2023

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 16

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

Exclusion Criteria

1. More than 3 tumors
2. Tumors larger than 3.5 cm
3. Solid tumors
4. Tumors with a large tumor base
5. Tumors in bladder diverticula

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence-free survival (RFS). For primary endpoint (recurrence) the time from operation to biopsy date, confirming the recurrence, is measured.

Secondary Outcome Measures

Name	Time	Method
<br> 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.<br> 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<br>