Skip to content

Clinical Trial Using Bipolar Technology for Transurethral Resection of Bladder Tumor

Using Biploar Technology for Transurethral Resection of Bladder Tumor - a Randomized Controlled Trial

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01581723
Enrollment
150
Registered
2012-04-20
Start date
2012-05-31
Completion date
2015-09-30
Last updated
2015-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Bladder Tumor

Keywords

urinary bladder tumor, monopolar TURBT, bipolar TURBT

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.

Interventions

DEVICEMonopolar diathermy

monopolar diathermy

bipolar diathermy

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Muscle sampling rateAn expected average of 7 days post operationTo assess the charring effect to the integrity of the tumor base biopsy
Incidence of TUR syndromeIntra-operation and up to 7 days post operation

Secondary

MeasureTime frame
Recurrence rate of bladder cancer3 months and 6 months after surgery

Countries

Hong Kong

Contacts

Primary ContactEddie SY Chan, MD
eddie@surgery.cuhk.edu.hk+852 2632 2625
Backup ContactCleo NY Lam, BSc
nylam@surgery.cuhk.edu.hk+852 2632 1663

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026