Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Bladder cancer is one of the most common types of cancer. If the cancer if discovered early, the first step in the treatment is a procedure called a transurethral resection of the bladder tumor (TURB). In this procedure, the surgeon will locate the visible tumors and cut them away from the lining of the bladder. This is done by inserting a scope called a cystoscope into the bladder through the urethra (the tube that carries urine out of the body). Attached to this scope is a small, electrified loop of wire which is moved back and forth through the tumor to cut and remove the tissue. These tissue samples are then sent to a laboratory so that the tumor can be examined and graded. Although this procedure aims to remove the entire tumor and prevent them coming back (recurrence), the recurrence of tumors is common. A possible reason for this is that tumor cells are left behind (shedding) in this procedure, and are free to move to other places in the bladder to form new tumors. En-bloc resection is a technique where the surgeon removes the tumor in one piece. This could prevent the tumor cell shedding that may lead to tumor recurrence. The aim of this study is to find out whether en-bloc resection causes less tumor cell shedding than traditional TURB, and whether this reduces the overall risk of recurrence. The study also aims to find out if the tissue samples from en-bloc resection can help the pathologists in the laboratory in their analysis.

Who can participate?
Adults with newly diagnosed bladder cancer, with one to three bladder tumors between 1 and 3.5 cm in diameter.

What does the study involve?
Participants are randomly allocated into two groups. The first group are treated with the transurethral en-bloc resection of the bladder tumor (TUEBR) procedure, and the second group are treated with the conventional transurethral resection of the bladder tumor (TURB) procedure.

What are the possible benefits and risks of participating?
There are no known benefits or risks with the use of en-bloc resection compared to conventional TURB.

Where is the study run from?
1. Department of Urology, Skåne University Hospital (Sweden)
2. Department of Surgery, Urological section, Uddevalla Hospital (Sweden)

When is the study starting and how long is it expected to run for?
June 2013 to May 2020

Who is funding the study?
Research Council (Vetenskapsrådet) (Sweden)

Who is the main contact?
Dr Oliver Patschan

Trial website

Contact information



Primary contact

Dr Oliver Patschan


Contact details

Department of Urology
Skåne University Hospital
Lund University
Jan Waldenströms gata 5
+46 40 332913

Additional identifiers

EudraCT number number

Protocol/serial number

Dnr 2013/23

Study information

Scientific title

Prospective randomised trial comparing transurethral en-bloc resection (TUEBR) with conventional transurethral resection (TURB) for bladder cancer


Study hypothesis

This study aims to investigate whether en-bloc resection of newly diagnosed bladder cancer tumors might lead to less tumor cell implantation in the bladder than conventional TURB. This in turn might translate into a reduced frequency of recurrent tumors. En-bloc resection might also lead to more.

Ethics approval

Regionala Etikprövningsnämnd (Sweden), 05/02/2013, ref: 2013/23

Study design

Multi-centre prospective randomised controlled trial.

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to requste a patient information sheet (only available in swedish).


Newly diagnosed bladder cancer (ICD10: C67.9)


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.

Intervention type



Drug names

Primary outcome measure

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

Secondary outcome measures

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants


Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Department of Urology
Skåne University Hospital Lund University Jan Waldenströms gata 5

Trial participating centre

Department of Surgery, Urological section
Urological Section Department of Surgery Uddevalla Hospital Fjällvägen 9

Sponsor information


Skåne University Hospital

Sponsor details

Department of Urology
Skåne University Hospital
Jan Waldenströms gata 5

Sponsor type

Hospital/treatment centre



Funder type

Not defined

Funder name

Research Council (Vetenskapsrådet)

Alternative name(s)

Swedish Research Council

Funding Body Type


Funding Body Subtype


Results and Publications

Publication and dissemination plan

Publication will be done on congresses (EAU, DGU, SUF) and hopefully in higher impact journals, since it is a prospective clinical trial. By now, it is extremely difficult to foresee the pace of the recruiting process, but I think it is realistic to publish preliminary data in 2017.

Intention to publish date


Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes