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Trial Title:
Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor
NCT ID:
NCT01581723
Condition:
Urinary Bladder Tumor
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
urinary bladder tumor
monopolar TURBT
bipolar TURBT
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Device
Intervention name:
Monopolar diathermy
Description:
monopolar diathermy
Arm group label:
Monopolar TUR
Other name:
Olympus Monopolar HF-resection Electrode
Other name:
Model: A22205A
Intervention type:
Device
Intervention name:
Bipolar diathermy
Description:
bipolar diathermy
Arm group label:
Biploar TUR
Other name:
Olympus TURis Bipolar HF-resection electrode
Other name:
Model: WA22306D
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Prince of Wales Hospital
Address:
City:
Shatin
Country:
Hong Kong
Status:
Recruiting
Investigator:
Last name:
Eddie SY Chan, MD
Email:
Principal Investigator
Investigator:
Last name:
Chi Fai Ng, MD
Email:
Sub-Investigator
Investigator:
Last name:
Simon SM Hou, MBBS
Email:
Sub-Investigator
Facility:
Name:
North District Hospital
Address:
City:
Sheung Shui
Country:
Hong Kong
Status:
Not yet recruiting
Investigator:
Last name:
Ho Yuen Cheung, MBChB
Email:
Sub-Investigator
Start date:
May 2012
Completion date:
September 2015
Lead sponsor:
Agency:
Chinese University of Hong Kong
Agency class:
Other
Source:
Chinese University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01581723
