Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix.
NCT ID: NCT01448798
Last Updated: 2011-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2011-10-31
2014-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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gelatine-thrombin matrix
Nerves-paring during robotic-assisted laparoscopic prostatectomy is conducted without mono- or bipolar electrocautery and clipping by using a hemostatic gelatine-thrombin matrix.
Application of a hemostatic gelatin-thrombin matrix
Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.
Control
Nerve-sparing during robotic-assisted radical prostatectomy is conducted with the use of mono- and bipolar electrocautery and surgical clipping.
Use of mono- and bipolar electrocautery and surgical clips
Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate.
Interventions
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Application of a hemostatic gelatin-thrombin matrix
Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.
Use of mono- and bipolar electrocautery and surgical clips
Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate.
Eligibility Criteria
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Inclusion Criteria
* Histologically proven prostate cancer ( Gleason \<8; PSA\<10ng/ml)
* Disease confined to prostate in clinical examination
* Preoperative IEEF-5-Score\>20
* Patient is able to give informed consent
Exclusion Criteria
* Prior extensive abdominal surgery
* Signs for metastatic disease
* Known allergy against bovine material
* Patient is unable to give informed consent
18 Years
MALE
No
Sponsors
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Johann Wolfgang Goethe University Hospital
OTHER
Responsible Party
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Axel Haferkamp
Prof. Dr. med. Axel Haferkamp
Principal Investigators
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Axel Haferkamp, Prof.
Role: PRINCIPAL_INVESTIGATOR
Johann Wolfgang Goethe University Hospitals, Germany
Locations
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Johann Wolfgang Goethe University Hospital
Frankfurt/M., , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AnPro
Identifier Type: -
Identifier Source: org_study_id