Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000290897
Ethics application status
Approved
Date submitted
11/03/2012
Date registered
13/03/2012
Date last updated
13/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Results after 50 first Endoscopic Extraperitoneal Radical Prostatectomies for Prostate Cancer.
Scientific title
Functional results, oncologic outcome and complications of 50 first EERPEs in a single centre without experience. A Prospective trial.
Secondary ID [1] 280104 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical treatment of localised prostate cancer 286018 0
Condition category
Condition code
Cancer 286205 286205 0 0
Prostate
Surgery 286206 286206 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Endoscopic Extraperitoneal Radical Prostatectomy for localised prostate cancer. The approximate duration of the procedure is anticipated to be 180-240 minutes.
Intervention code [1] 284430 0
Treatment: Surgery
Comparator / control treatment
Single group trial
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286681 0
Potency and Continence before and after EERPE. These parameters are going to be assessed by a single question for each:
For Potency ''Do you have normal erections without the use of PDE-5 inhibitors?'' If the answer is YES we consider the patient potent and via versa.
For Continence ''Is there any urinary incontinence?'' If the answer is NO and there is not leakage at all we consider the patient continent and via versa.
Timepoint [1] 286681 0
On day before the surgery and on 3 months.
Primary outcome [2] 286682 0
Surgical complications after the operation using the modified Clavien System.
Timepoint [2] 286682 0
All the complications are going to be recorded during the early and late postoperatively day. On dishcarge day and on 3 months.
Primary outcome [3] 286683 0
Oncologic outcome. This is going to be assessed by means of PSM (Positive Surgical Margins) and PSA.
Timepoint [3] 286683 0
When the histopathologic data are ready and PSA on 3 months.
Secondary outcome [1] 296448 0
Length of hospital stay (Days).
Timepoint [1] 296448 0
On discharge day.
Secondary outcome [2] 296449 0
Catheter duration (days).
Timepoint [2] 296449 0
On catheter removal day.
Secondary outcome [3] 296450 0
Pelvic drainage (days).
Timepoint [3] 296450 0
On discharge day.
Secondary outcome [4] 296451 0
Drop in serum Hb from preoperatively to discharge
Timepoint [4] 296451 0
On discharge day.
Secondary outcome [5] 296452 0
Operative time of the procedure in Minutes.
Timepoint [5] 296452 0
At the end of the operation.
Secondary outcome [6] 296453 0
If lymph node dissection was carried out.
Timepoint [6] 296453 0
At the end of the operation.
Secondary outcome [7] 296454 0
If Nerve Sparing technique was attempted.
Timepoint [7] 296454 0
At the end of the operation.

Eligibility
Key inclusion criteria
Clinical localised prostate cancer.
Life expectancy of greater than 10 years.
The appropriate metastatic workup results are negative.
Minimum age
40 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Locally advanced disease.
Metastatic disease.

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 4190 0
Greece
State/province [1] 4190 0

Funding & Sponsors
Funding source category [1] 284866 0
Self funded/Unfunded
Name [1] 284866 0
Country [1] 284866 0
Primary sponsor type
Hospital
Name
Gennimatas General Hospital of Thessaloniki
Address
41 Ethnikis Aminis, Thessaloniki, 54643
Country
Greece
Secondary sponsor category [1] 283744 0
None
Name [1] 283744 0
Address [1] 283744 0
Country [1] 283744 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
EERPE is an alternative surgical method in the treatment of localised prostate cancer, but all surgeons are not yet familiar with laparoscopic skillis. This study is initiating to evaluate this procedure with regard to continence, erectile function and oncologic outcome in a single centre without previous experience.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33888 0
Address 33888 0
Country 33888 0
Phone 33888 0
Fax 33888 0
Email 33888 0
Contact person for public queries
Name 17135 0
Kampantais Spyridon
Address 17135 0
41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 17135 0
Greece
Phone 17135 0
+30 6945375525
Fax 17135 0
Email 17135 0
[email protected]
Contact person for scientific queries
Name 8063 0
Kampantais Spyridon
Address 8063 0
41 Ethnikis Aminis Street, Thessaloniki, 54643
Country 8063 0
Greece
Phone 8063 0
+30 6945375525
Fax 8063 0
Email 8063 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.