Bladder cancer: Open versus Laparoscopic or RObotic cystectomy

Completed

• Conditions: Invasive bladder cancer; Cancer; Malignant neoplasm of bladder

• Registration Number: ISRCTN38528926
• Lead Sponsor: Cardiff University (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12-11
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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