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Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

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ClinicalTrials.gov Identifier: NCT01581723
Recruitment Status : Unknown
Verified February 2015 by Eddie SY Chan, MD, Chinese University of Hong Kong.
Recruitment status was:  Recruiting
First Posted : April 20, 2012
Last Update Posted : February 4, 2015
Sponsor:
Information provided by (Responsible Party):
Eddie SY Chan, MD, Chinese University of Hong Kong

Tracking Information
First Submitted Date  ICMJE March 21, 2012
First Posted Date  ICMJE April 20, 2012
Last Update Posted Date February 4, 2015
Study Start Date  ICMJE May 2012
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
  • Muscle sampling rate [ Time Frame: 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 [ Time Frame: Intra-operation and up to 7 days post operation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2012)
Recurrence rate of bladder cancer [ Time Frame: 3 months and 6 months after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor
Official Title  ICMJE Using Biploar Technology for Transurethral Resection of Bladder Tumor - a Randomized Controlled Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Urinary Bladder Tumor
Intervention  ICMJE
  • Device: Monopolar diathermy
    monopolar diathermy
    Other Names:
    • Olympus Monopolar HF-resection Electrode
    • Model: A22205A
  • Device: Bipolar diathermy
    bipolar diathermy
    Other Names:
    • Olympus TURis Bipolar HF-resection electrode
    • Model: WA22306D
Study Arms  ICMJE
  • Active Comparator: Monopolar TUR
    Monopolar diathermy is used to perform tranurethral resection of bladder tumor
    Intervention: Device: Monopolar diathermy
  • Experimental: Biploar TUR
    Bipolar diathermy is used to perform transurethral resection of bladder tumor
    Intervention: Device: Bipolar diathermy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 19, 2012)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2015
Estimated Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01581723
Other Study ID Numbers  ICMJE CUHK_TURB_2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eddie SY Chan, MD, Chinese University of Hong Kong
Study Sponsor  ICMJE Chinese University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eddie SY Chan, MD Chinese University of Hong Kong
PRS Account Chinese University of Hong Kong
Verification Date February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP