Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix.
AnPro
Prospective Randomized Investigation of Athermal Nerve-sparing During Robotic-assisted Laparoscopic Prostatectomy Using a Hemostatic Gelatin-thrombin Matrix
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of this study is to evaluate the use of a hemostatic gelatine-thrombin matrix during athermal nerve-sparing prostate resection compared to conventional hemostasis using electrocautery in patients with localized prostate cancer and to investigate effects on postoperative erectile function and continence.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable prostate-cancer
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 6, 2011
CompletedFirst Posted
Study publicly available on registry
October 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedOctober 7, 2011
October 1, 2011
1.3 years
October 6, 2011
October 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative erectile function
Postoperative erectile function compared to preoperative status assessed validated questionnaires.
12 months
Secondary Outcomes (3)
Postoperative continence
12 months
Intraoperative bloodloss
During surgery
Intra- and postoperative complications
Perioperative period
Study Arms (2)
gelatine-thrombin matrix
EXPERIMENTALNerves-paring during robotic-assisted laparoscopic prostatectomy is conducted without mono- or bipolar electrocautery and clipping by using a hemostatic gelatine-thrombin matrix.
Control
SHAM COMPARATORNerve-sparing during robotic-assisted radical prostatectomy is conducted with the use of mono- and bipolar electrocautery and surgical clipping.
Interventions
Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.
Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate.
Eligibility Criteria
You may qualify if:
- Patient age \>18
- 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
You may not qualify if:
- ASA IV-V
- Prior extensive abdominal surgery
- Signs for metastatic disease
- Known allergy against bovine material
- Patient is unable to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Johann Wolfgang Goethe University Hospital
Frankfurt/M., 60590, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Axel Haferkamp, Prof.
Johann Wolfgang Goethe University Hospitals, Germany
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Axel Haferkamp
Study Record Dates
First Submitted
October 6, 2011
First Posted
October 7, 2011
Study Start
October 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2014
Last Updated
October 7, 2011
Record last verified: 2011-10