Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

Phase 3

• Conditions: Urinary Bladder Tumor
• Interventions: Device: Monopolar diathermy; Device: Bipolar diathermy

• Registration Number: NCT01581723
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-20
• Study Start: 2012-05
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-04
• Primary Completion: 2015-06
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Adult male or female patients (age ≥ 18)
• Patients who have diagnosed with bladder cancer (either primary or recurrent) by cystoscopy

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Exclusion Criteria

• Patients who are scheduled for second TUR within 6 weeks after the previous TUR

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monopolar TUR	Monopolar diathermy	Monopolar diathermy is used to perform tranurethral resection of bladder tumor
Biploar TUR	Bipolar diathermy	Bipolar diathermy is used to perform transurethral resection of bladder tumor

Primary Outcome Measures

Name	Time	Method
Muscle sampling rate	An expected average of 7 days post operation	To assess the charring effect to the integrity of the tumor base biopsy
Incidence of TUR syndrome	Intra-operation and up to 7 days post operation

Secondary Outcome Measures

Name	Time	Method
Recurrence rate of bladder cancer	3 months and 6 months after surgery

Trial Locations

Locations (2)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong

North District Hospital; 🇭🇰 Sheung Shui, Hong Kong