Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000072011
Ethics application status
Approved
Date submitted
17/01/2010
Date registered
20/01/2010
Date last updated
20/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Transurethral Enucleation and Resection of Prostate versus Transvesical Prostatectomy for Prostate greater than 80ml: A Prospective Randomized Study
Scientific title
Transurethral Enucleation and Resection of Prostate and Transvesical Prostatectomy for benign prostate hyperplasia (BPH) patients with prostate volume greater than 80ml, the primary outcomes include International Prostate Symptom Score (IPSS) and Quality of Life Score (QoLS)
Secondary ID [1] 1306 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
benign proaste hyperplasia 256567 0
Condition category
Condition code
Renal and Urogenital 256738 256738 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
transvesical prostatectomy (TVP) (1.5hours): The prostate is enucleated through abdominal routh, this is an open surgery. Surgeon removes the adenoma bluntly via finger dissection.
and transurethral enucleation and resection of the prostate (TUERP)(1.5hours): this is a transurethral procedure. Steps: to develop the plane of surgical capsule at the level closely proximal to the verumontanum with vaporization, dissecting the adenoma off the capsule plane by unclenching the adenoma bluntly using the beak of the resectoscope sheath from one side to the other, just like finger dissection in TVP procedure. The blood vessels to the adenoma were coagulated at the time of dissection. When the whole adenoma was almost dissected off the capsule, a small proportion of adenoma was allowed to anchor the capsule at the bladder neck which helped the surgeon to harvest the whole adenoma into pieces with resection. The adenoma slices can be evacuated manually.
Intervention code [1] 255836 0
Treatment: Surgery
Comparator / control treatment
transurethral enucleation and resection of the prostate (1.5hours)
Control group
Active

Outcomes
Primary outcome [1] 257624 0
International prostate symptom score(IPSS)
Timepoint [1] 257624 0
at 12 months after surgery
Primary outcome [2] 257646 0
Quality of Life Scale (QOLS)
Timepoint [2] 257646 0
at 12 months after surgery
Secondary outcome [1] 262897 0
postvoid residual(PVR): PVR is measured by ultrasound or catheterization
Timepoint [1] 262897 0
at 12 months after surgery

Eligibility
Key inclusion criteria
benign prostate hyperplasia (BPH) with prostate>80ml: The prostate volume is measured by transrectal ultrasound conform to this equation: the volume equals 0.52 × (L × W × H), where L is the maximum length (craniocaudal dimension), H is the maximum height (anteroposterior dimension), both were obtained from the sagittal plane, W is the maximum width (transverse dimension) obtained from the transverse plane.
Minimum age
50 Years
Maximum age
90 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
neurologic problem and Bladder stone

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2411 0
China
State/province [1] 2411 0

Funding & Sponsors
Funding source category [1] 256349 0
Hospital
Name [1] 256349 0
Guangzhou First Municipal People's Hospital
Country [1] 256349 0
China
Primary sponsor type
Individual
Name
xie, keji
Address
No 1, Panfu Rd, Yuexiu District, Guangzhou
Country
China
Secondary sponsor category [1] 251662 0
Individual
Name [1] 251662 0
Liu, Chunxiao
Address [1] 251662 0
No 253, Gongyue Dadaozhong Rd, Guangzhou
Country [1] 251662 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The surgical management of patients with prostate greater than 80ml that cause bladder outflow obstruction secondary to benign prostatic hyperplasia (BPH) is a challenging area.AUA and EAU guidelines suggest that open prostatectomy should be the treatment of choice in patients with a prostate volume of greater than 80ml. Transvesical prostatectomy (TVP) is a popular open prostatectomy, however, the application of it for large prostate has been progressively decreasing over the years following the rapid advent of minimally invasive techniques. Transurethral enucleation and resection of prostate (TUERP) with Gyrus Plasma Kinetic System is an unique surgery which was initiated by a Chinese doctor and popularized around the country and propagated to the world in AUA Meeting (2006). The unique feature of this procedure is that prostate is transurethrally enucleated and resected with bipolar plasmakinetic resectoscope. Previous studies reported the satisfactory efficacy and safety of TUERP in treating BPH, however, prostate volume in these report ranged from small to large size. Our goal is to assess the efficacy and safety of TUERP in treating BPH with prostate greater than 80 ml. If it does work, it will provide a new minimally invasive technique for large prostate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30717 0
Address 30717 0
Country 30717 0
Phone 30717 0
Fax 30717 0
Email 30717 0
Contact person for public queries
Name 13964 0
keji xie
Address 13964 0
no 1, panfu Rd, Yuexiu District, Guangzhou
Country 13964 0
China
Phone 13964 0
011-86-20-81048268
Fax 13964 0
Email 13964 0
[email protected]
Contact person for scientific queries
Name 4892 0
rubiao ou
Address 4892 0
no 1, panfu Rd, Yuexiu District, Guangzhou
Country 4892 0
China
Phone 4892 0
011-86-20-81048268
Fax 4892 0
Email 4892 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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