Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000012774
Ethics application status
Approved
Date submitted
6/12/2012
Date registered
7/01/2013
Date last updated
7/01/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Relationship between percent of resected tissue and symptom improvement after surgical treatment of benign prostatic hyperplasia.
Scientific title
Impact of the percent of resected tissue on the symptom improvement at surgical treatment of benign prostatic hyperplasia. A prospective analysis.
Secondary ID [1] 281559 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical treatment of benign prostate hyperplasia 287841 0
Condition category
Condition code
Renal and Urogenital 288185 288185 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Surgical resection of prostate by one of the following surgical techniques (three different interventions)
1. TURP (transurethral resection of prostate, one hour duration)
2. Freyer's prostatectomy (open transvesical prostatectomy, one and a half hour duration)
3. Millin prostatectomy (open retropubic transcapsular resection of prostate, one and a half hour duration)
Intervention code [1] 286075 0
Treatment: Surgery
Comparator / control treatment
Trnasurethral Resection of Prostate (TURP)
Control group
Active

Outcomes
Primary outcome [1] 288384 0
Estimate the percent of resected tissue and collerate this with the improvement on urinary symptoms
Timepoint [1] 288384 0
The percent of resected tissue is going to be calculated as the resected tissue weight divided by the preoperative prostate weight x 100. The preoperative prostate weight is going to be estimated as the preoperative prostate volume x specific gravity of prostate. The prostate tissue collected at resection is going to be weighed and multiplied by 1.2 to compensate for 'shrinkage' (resected tissue weight).
The improvement on symptoms is going to be assessed with the questionnaire of International Prostate Symptom Score (IPSS), the extra question for quality of life (QoL), the post-void residual (PVR) urine volume and the Qmax in uroflowmetry. All these are going to be estimated preoperatively and three (3) months after the procedure.
Secondary outcome [1] 300010 0
If the increased amount of removed tissue influence the spontaneous detection of prostate cancer during surgical treatment of BPH(Benign Prostate Hyperplasia).
Timepoint [1] 300010 0
Postoperatively with the histopathologic examination. As it is known, prostate cancer more frequently is developed in the peripheral zone of prostate. So by increasing the amount of tissue resected, theoritically get closed to the peripheral zone of the prostate.

Eligibility
Key inclusion criteria
1. Patients with moderate or severe LUTS (lower urinary tracts symptoms) due to BPH (benign prostatic hyperplasia) that are refractory to medical treatment
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients with prostatic carcinoma
2. Patients with neurogenic bladder
3. Patients with Foley catheter that are going to be treated due to urinary retention

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2013
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] 4734 0
Greece
State/province [1] 4734 0

Funding & Sponsors
Funding source category [1] 286380 0
Self funded/Unfunded
Name [1] 286380 0
Country [1] 286380 0
Primary sponsor type
Hospital
Name
Gennimatas General Hospital of Thessaloniki
Address
41 Ethnikis Aminis, Thessaloniki, 54643
Country
Greece
Secondary sponsor category [1] 285168 0
None
Name [1] 285168 0
Address [1] 285168 0
Country [1] 285168 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Changes in prostate volume before and after
surgical treatment for BPH have been reported, but only few
studies have assessed the correlation between the percent of resected tissue and the clinical outcome. To evaluate this colleration in men treated either with TURP or open prostatectomy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34966 0
Dr Kampantais Spyridon
Address 34966 0
12 Gennimata street, Thessaloniki, 55132
Country 34966 0
Greece
Phone 34966 0
+302314011161
Fax 34966 0
Email 34966 0
[email protected]
Contact person for public queries
Name 18213 0
Dr Kampantais Spyridon
Address 18213 0
12 Gennimata street, Thessaloniki, 55132
Country 18213 0
Greece
Phone 18213 0
+302314011161
Fax 18213 0
Email 18213 0
[email protected]
Contact person for scientific queries
Name 9141 0
Dr Kampantais Spyridon
Address 9141 0
12 Gennimata street, Thessaloniki, 55132
Country 9141 0
Greece
Phone 9141 0
+302314011161
Fax 9141 0
Email 9141 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
No additional documents have been identified.