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.
Transurethral resection (TUR) of bladder tumor is one of commonest procedures in urology
practice. It is the surgery of choice for staging and treating non-muscle invasive bladder
cancer. Short lengths of hospital stay, simple and safe are the main advantages of the
surgery. Conventional TUR is performed with monopolar diathermy, which commonly elicits
obturator reflexes in lateral-located tumor. However, it is not without complication.
Bleeding and bladder perforation with or without obturator reflex are the most significant
complications after TUR of bladder tumor. The charring effect of monopolar is also a concern
as the diagnosis of muscle invasion by tumor is determined by the integrity of tumor base
biopsy. Mariappan et al. reported that as high as 33% of the specimen had no detrusor muscle
present for assessment. The absent of muscle not only affect the staging procedure but also
associated with higher cancer recurrence rate.
Bipolar resection has been widely used in transurethral resection of prostate (TURP). As
compared with the traditional monopolar technology, the electric current passes through the
instrument sheath. The advantage of bipolar technology includes less obturator reflex, good
hemostasis and early recovery. Study has showed that the cautery artifact is more severe on
monopolar resection as compared with bipolar in prostate tissues. Due to the clean and
precise cutting, there will be less charring on the specimen and thermal injury to
peripheral tissues. Applying to bladder tumor resection, this will improve the staging
accuracy with better determination of the depth of invasion. Furthermore, with the use of
saline instead of glycine as irrigation fluid, risk of TUR syndrome is minimized. There is
no randomized trial on the benefit of using bipolar instrument on TUR bladder cancer. In
this study, investigator will investigate the role of bipolar technology in TUR bladder
cancer as compared with traditional monopolar resection.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment