Bladder cancer: Open versus Laparoscopic or RObotic cystectomy

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

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.