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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002732
Receipt No. R000003146
Scientific Title Does histological evidence support the hypothesis that Open radical prostatectomy with Veil of Aphrodite enhances urinary continence
Date of disclosure of the study information 2009/11/09
Last modified on 2011/05/09

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Basic information
Public title Does histological evidence support the hypothesis that Open radical prostatectomy with Veil of Aphrodite enhances urinary continence

Acronym The efficacy of Veil of Aphrodite technique on early recovery of urinary continence
Scientific Title Does histological evidence support the hypothesis that Open radical prostatectomy with Veil of Aphrodite enhances urinary continence

Scientific Title:Acronym The efficacy of Veil of Aphrodite technique on early recovery of urinary continence
Region
Japan

Condition
Condition Clinically localized prostatic cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Urinary incontinence as well as erectile dysfunction is the most common complication following radical prostatectomy. Although the introduction of Robotic Assisted Radical Prostatectomy seems to open the door to a new era in terms of surgical skills and anatomical knowledge, postoperative complications remain challenging. Several recent studies show that the preservation of prostatic fascia is associated with urinary continence after radical prostatectomy. Microanatomical studies have revealed that a significant amount of nerve fibers in the prostatic fascia, especially along the anterolateral circumference, form a periprostatic nerve network. The branches of this periprostatic nerve network provide innervations to the urethra to contribute to continence. In order to preserve as many of these nerves as possible, a modified technique (Veil of Aphrodite) to directly incise the prostatic fascia to the prostate anteriorly was introduced.
To our knowledge, this is the first study to analyze the benefit of open radical prostatectomy with the Veil of Aphrodite technique by evaluating the correlation between histological evidence and urinary continence.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Clinically localized prostate cancer patients take open radical prostatectomy with Veil of Aphrodite technique. In pathologic specimens, anterolateral zones of each prostate are independently evaluated for margin clearance and quantitative analysis of periprostaic nerve bundles using S100 immunostain. Return of continence is evaluated at one week after catheter removal. Evaluations are performed using the 24-hour pad test.

Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Introduction of Veilof Aporodite technique to preserve urinary continence.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
45 years-old <=
Age-upper limit
80 years-old >
Gender Male
Key inclusion criteria clinically localized prostate cancer
Key exclusion criteria IPSS<7
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mitsuko Yasuda
Organization Satte General Hospital
Division name Department of Urology
Zip code
Address 4-14-24 Satte-Higashi, Sateshi, Saitama-ken, Japan
TEL 0480-42-1211
Email

Public contact
Name of contact person
1st name
Middle name
Last name Mitsuko Yasuda
Organization Satte General Hospital
Division name Department of Urology
Zip code
Address 4-14-24 Satte-Higashi, Sateshi, Saitama-ken, Japan
TEL 0480-42-1211
Homepage URL
Email

Sponsor
Institute Satte General Hospital
Institute
Department

Funding Source
Organization Satte General Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions JA埼玉県厚生連幸手総合病院

Other administrative information
Date of disclosure of the study information
2009 Year 11 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 04 Day
Date of IRB
Anticipated trial start date
2009 Year 11 Month 01 Day
Last follow-up date
2011 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 11 Month 09 Day
Last modified on
2011 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003146

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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