Urinary Bladder Tumor Clinical Trial
Official title:
Using Biploar Technology for Transurethral Resection of Bladder Tumor - a Randomized Controlled Trial
Bladder cancer is a common urological malignant disease. Patients with bladder cancer will first be managed with transurethral resection (TUR) of bladder tumor. For many years, monopolar transurethral resection of bladder tumor (TURP) has been the gold standard for treatment. However, complications including bleeding, bladder perforation and inadequate sampling of deep tumor biopsy remain the major concerns. Recently published papers suggested that the newer bipolar TUR technology has similar surgical outcomes but less complications comparing with monopolar TUR. In this study, investigators will investigate the benefit of new technology as compared with conventional monopolar resection on tumor clearance, complication and recurrence rates.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | September 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Adult male or female patients (age = 18) - Patients who have diagnosed with bladder cancer (either primary or recurrent) by cystoscopy Exclusion Criteria: - Patients who are scheduled for second TUR within 6 weeks after the previous TUR |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital | Shatin | |
Hong Kong | North District Hospital | Sheung Shui |
Lead Sponsor | Collaborator |
---|---|
Chinese University of Hong Kong |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Muscle sampling rate | To assess the charring effect to the integrity of the tumor base biopsy | An expected average of 7 days post operation | No |
Primary | Incidence of TUR syndrome | Intra-operation and up to 7 days post operation | Yes | |
Secondary | Recurrence rate of bladder cancer | 3 months and 6 months after surgery | No |