Robotic-assisted versus open removal of the bladder in bladder cancer patients

Robotic-Assisted radical Cystectomy vErsus open Radical cystectomy: a randomised non-inferiority trial comparing 3-year recurrence-free survival in patients undergoing cystectomy for urothelial carcinoma of the bladder

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN64538003

Enrollment

488

Registered

2019-11-04

Start date

2019-11-04

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder cancer Cancer Malignant neoplasm of bladder

Interventions

For both the treatment arms, eligible patients will be offered neo-adjuvant or induction chemotherapy. Randomisation to robot assisted or open surgery will be performed after any preoperative chemothe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically verified urothelial cancer 2. cT1-4a or BCG-unresponsive CIS 3. N0-1, or N2-3 if response on pre-operative chemotherapy to N0-1 4. Able to sign informed consent

Exclusion criteria

Exclusion criteria: 1. Distant metastasis (M1) 2. Unfit for either type of procedure 3. Extant ileo- or colostomy 4. Duplicated ureters

Design outcomes

Primary

Measure	Time frame
Progression-free survival at three years following cystectomy	—

Secondary

Measure	Time frame
Surgical outcomes: 1. Rate of complications 2. Blood loss 3. Rate of transfusion 4. Time of stay Long-term outcomes: 5. Rate of unplanned readmission 6. Quality of life measured by questionnaires FACT-G/Bl-Cys and WHODAS2.0 at baseline, and 3, 6 and 12 months and EQ-5D-5L at baseline and weekly for the first 4 postoperative weeks 7. Total health-care related costs following cystectomy, calculated for the direct and indirect costs related to the surgery for the first 6 months	—

Measure

Time frame

Surgical outcomes: 1. Rate of complications 2. Blood loss 3. Rate of transfusion 4. Time of stay Long-term outcomes: 5. Rate of unplanned readmission 6. Quality of life measured by questionnaires FACT-G/Bl-Cys and WHODAS2.0 at baseline, and 3, 6 and 12 months and EQ-5D-5L at baseline and weekly for the first 4 postoperative weeks 7. Total health-care related costs following cystectomy, calculated for the direct and indirect costs related to the surgery for the first 6 months

—

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026