Open, laparoscopic and robotic radical cystectomy for bladder cancer

A pilot randomized controlled trial of open, laparoscopic and robotic radical cystectomy for bladder cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN28499748

Enrollment

141

Registered

2014-09-30

Start date

2008-11-01

Completion date

Unknown

Last updated

2017-07-03

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

Conditions

Bladder cancer Cancer

Interventions

Patients consenting to participate were randomly assigned using the sealed envelope method to one of three surgical procedures (conventional, open abdominal surgery or laparoscopic or robot assisted m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 18-80 2. Sex-Male or female 3. Able to give informed consent 4. Proven muscle invasive bladder cancer or uncontrolled superficial bladder cancer requiring cystectomy . 5. Fit for major surgery

Exclusion criteria

Exclusion criteria: 1. Previous extensive abdominal or pelvic surgery 2. Previous treatment with external beam therapy or history of pelvic irradiation 3. Uncontrolled bleeding disorder 4. Unfit for major surgery 5. Unable to give informed consent 6. Pregnancy

Design outcomes

Primary

Measure	Time frame
1. To determine the best methods of recruitment for the study, and the likely uptake of patients to facilitate future sample size estimates. 2. To determine patients and families likelihood of agreeing to participate in repeated interviews, the best time period for re-interview and the likely attrition from the study. After discharge, all patients received routine clinical review at 2 weeks, 3, 6, and 12 months , and then yearly thereafter. Patient reported outcomes were sought using the validated questionnaire Functional Assessment of Cancer therapy - Bladder ( FACT - BL) at each visit to clinic in their first year and yearly after that.	—

Measure

Time frame

1. To determine the best methods of recruitment for the study, and the likely uptake of patients to facilitate future sample size estimates. 2. To determine patients and families likelihood of agreeing to participate in repeated interviews, the best time period for re-interview and the likely attrition from the study. After discharge, all patients received routine clinical review at 2 weeks, 3, 6, and 12 months , and then yearly thereafter. Patient reported outcomes were sought using the validated questionnaire Functional Assessment of Cancer therapy - Bladder ( FACT - BL) at each visit to clinic in their first year and yearly after that.

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Secondary

Measure	Time frame
1. To determine the most appropriate methods of capturing data on symptoms, quality of life, preferences and experience among patients with the different methods of surgery to remove the urinary bladder 2. To determine the most appropriate methods of analysis of the study, in particular how to handle missing data due to attrition 3. To determine primary clinical outcome- composite complication rates such as transfusion, urine leakage, ileus, bowel leak/obstruction, cardiovascular and respiratory complications 4. To determine primary economic outcome: length of post-operative hospital stay (LOS) 5. To determine estimated blood loss, operative time 6. To determine economic evaluation: cost implications of clinical outcomes i.e., complications, LOS (based on unit daily cost of a NHS bed along with surgical, nursing and pharmaceutical support calculated at £500/day), blood loss, return to normal activity as studied by the physical and mental domains of the SF-8 questionnaire. 7. Economic modelling: Markov model and Monte Carlo simulation of the long term follow-up: 90-day readmission; 1-year potency in those previously potent; 1-year quality of life (SF-8); 2 year metastasis rate; 5-year RFS 8. Sample size calculation ? 141 patients with 47 in each arm As per local protocol, loopogram studies were performed at 3 months to assess for uretero-enteric anastomotic strictures. Computed tomography (CT) scans of the chest, abdomen and pelvis were performed at 6 and 12 months to assess for recurrence	—

Measure

Time frame

1. To determine the most appropriate methods of capturing data on symptoms, quality of life, preferences and experience among patients with the different methods of surgery to remove the urinary bladder 2. To determine the most appropriate methods of analysis of the study, in particular how to handle missing data due to attrition 3. To determine primary clinical outcome- composite complication rates such as transfusion, urine leakage, ileus, bowel leak/obstruction, cardiovascular and respiratory complications 4. To determine primary economic outcome: length of post-operative hospital stay (LOS) 5. To determine estimated blood loss, operative time 6. To determine economic evaluation: cost implications of clinical outcomes i.e., complications, LOS (based on unit daily cost of a NHS bed along with surgical, nursing and pharmaceutical support calculated at £500/day), blood loss, return to normal activity as studied by the physical and mental domains of the SF-8 questionnaire. 7. Economic modelling: Markov model and Monte Carlo simulation of the long term follow-up: 90-day readmission; 1-year potency in those previously potent; 1-year quality of life (SF-8); 2 year metastasis rate; 5-year RFS 8. Sample size calculation ? 141 patients with 47 in each arm As per local protocol, loopogram studies were performed at 3 months to assess for uretero-enteric anastomotic strictures. Computed tomography (CT) scans of the chest, abdomen and pelvis were performed at 6 and 12 months to assess for recurrence

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Countries

United Kingdom

Outcome results

None listed

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