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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12612000290897 |
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Date of registration:
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13/03/2012 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Results after 50 first Endoscopic Extraperitoneal Radical Prostatectomies for Prostate Cancer.
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Scientific title:
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Functional results, oncologic outcome and complications of 50 first EERPEs in a single centre without experience. A Prospective trial. |
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Date of first enrolment:
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01/05/2012 |
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Target sample size:
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50 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://anzctr.org.au/ACTRN12612000290897.aspx |
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Study type:
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Interventional |
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Study design:
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Purpose: Treatment; Allocation: Non-randomised trial; Assignment: Single group;
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Phase:
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Not Applicable
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Countries of recruitment
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Greece
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Contacts
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Name:
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Kampantais Spyridon
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Address:
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41 Ethnikis Aminis Street, Thessaloniki, 54643
Greece |
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Telephone:
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+30 6945375525 |
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Email:
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kabspir@hotmail.com |
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Affiliation:
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Name:
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Kampantais Spyridon
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Address:
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41 Ethnikis Aminis Street, Thessaloniki, 54643
Greece |
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Telephone:
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+30 6945375525 |
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Email:
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kabspir@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Clinical localised prostate cancer.
Life expectancy of greater than 10 years.
The appropriate metastatic workup results are negative.
Exclusion criteria: Locally advanced disease.
Metastatic disease.
Age minimum:
40 Years
Age maximum:
No limit
Gender:
Males
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Health Condition(s) or Problem(s) studied
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Cancer - Prostate
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Surgery - Surgical techniques
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Surgical treatment of localised prostate cancer;
Surgical treatment of localised prostate cancer
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Intervention(s)
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Endoscopic Extraperitoneal Radical Prostatectomy for localised prostate cancer. The approximate duration of the procedure is anticipated to be 180-240 minutes.
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Primary Outcome(s)
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Oncologic outcome. This is going to be assessed by means of PSM (Positive Surgical Margins) and PSA.[When the histopathologic data are ready and PSA on 3 months.]
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Surgical complications after the operation using the modified Clavien System.[All the complications are going to be recorded during the early and late postoperatively day. On dishcarge day and on 3 months.]
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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.[On day before the surgery and on 3 months.]
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Secondary Outcome(s)
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Catheter duration (days).[On catheter removal day.]
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Drop in serum Hb from preoperatively to discharge[On discharge day.]
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If lymph node dissection was carried out.[At the end of the operation.]
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If Nerve Sparing technique was attempted.[At the end of the operation.]
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Operative time of the procedure in Minutes.[At the end of the operation.]
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Length of hospital stay (Days).[On discharge day.]
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Pelvic drainage (days).[On discharge day.]
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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