Bladder cancer: Open versus Laparoscopic or RObotic cystectomy

A study to determine the feasibility of randomisation to open versus minimal access cystectomy in patients with muscle invasive bladder cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38528926

Enrollment

Registered

2008-12-11

Start date

2011-01-17

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Invasive bladder cancer Cancer Malignant neoplasm of bladder

Interventions

Arm A: Open radical cystectomy Arm B: Minimal radical cystectomy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females, aged >=16 years 2. American Society of Anaesthesiologists (ASA) score 1 or 2 3. Histopathological confirmation of urothelial cell carcinoma (UCC), squamous cell carcinoma (SCC) or adenocarcinoma of the bladder 4. pT1 or pT2, and mobile mass, on examination under anaesthesia 5. Computerised tomography (CT) scan of abdomen/pelvis indicating no enlarged nodes or distant metastases 6. If neo-adjuvant chemotherapy has been administered, surgery must be between 3 and 6 weeks from the last date of chemotherapy 7. Written, informed consent

Exclusion criteria

Exclusion criteria: 1. Prostatic urethral disease or upper tract disease 2. Concomitant disease that would render the patient unsuitable for the study 3. Presence of urosepsis

Design outcomes

Primary

Measure	Time frame
Feasibility of randomisation defined as >=60% of registered patients accepting randomisation to open versus minimal access cystectomy.	—

Secondary

Measure	Time frame
1. To determine the safety and efficacy of minimal versus open access cystectomy, including an assessment of the extent of lymph node dissection, short term morbidity and complications associated with surgery to open surgery 2. To determine the potential barriers to randomisation in patients who consent to registration and do not accept randomisation, via Quality Assessment interview of this patient pool 3. To determine potential factors relating to non-registration of patients with muscle invasive bladder cancer who are eligible for inclusion but have not been registered, based on review of screening logs Timepoints of assessment for the secondary outcome measures 1-3 above have not been finalised as of 07/10/2008. Exploratory outcome measures: 4. Morbidity assessment at 6 weeks from the date of discharge, then 3 monthly over a period of 24 months 5. Operative, peri-operative (<30 days) and late exploratory assessment (<180 days), including 90 and 180 day mortality 6. Oncological outcomes, including total number of lymph nodes resected and evidence of disease progression on CT scan at 6 and 12 months 7. Quality of life assessment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the muscle invasive bladder cancer module (EORTC QLQ-BLS24). Quality of life assessments will be performed in a subgroup of 20 participants, within 14 days of randomisation, 4, 6 and 8 weeks, and 3, 6 and 12 months after date of cystectomy.	—

Measure

Time frame

1. To determine the safety and efficacy of minimal versus open access cystectomy, including an assessment of the extent of lymph node dissection, short term morbidity and complications associated with surgery to open surgery 2. To determine the potential barriers to randomisation in patients who consent to registration and do not accept randomisation, via Quality Assessment interview of this patient pool 3. To determine potential factors relating to non-registration of patients with muscle invasive bladder cancer who are eligible for inclusion but have not been registered, based on review of screening logs Timepoints of assessment for the secondary outcome measures 1-3 above have not been finalised as of 07/10/2008. Exploratory outcome measures: 4. Morbidity assessment at 6 weeks from the date of discharge, then 3 monthly over a period of 24 months 5. Operative, peri-operative (<30 days) and late exploratory assessment (<180 days), including 90 and 180 day mortality 6. Oncological outcomes, including total number of lymph nodes resected and evidence of disease progression on CT scan at 6 and 12 months 7. Quality of life assessment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the muscle invasive bladder cancer module (EORTC QLQ-BLS24). Quality of life assessments will be performed in a subgroup of 20 participants, within 14 days of randomisation, 4, 6 and 8 weeks, and 3, 6 and 12 months after date of cystectomy.

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 2, 2026