Trial Information
Prospective Randomized Investigation of Athermal Nerve-sparing During Robotic-assisted Laparoscopic Prostatectomy Using a Hemostatic Gelatin-thrombin Matrix
Inclusion Criteria:
- 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
Exclusion Criteria:
- ASA IV-V
- Prior extensive abdominal surgery
- Signs for metastatic disease
- Known allergy against bovine material
- Patient is unable to give informed consent
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Postoperative erectile function
Outcome Description:
Postoperative erectile function compared to preoperative status assessed validated questionnaires.
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Axel Haferkamp, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Johann Wolfgang Goethe University Hospitals, Germany
Authority:
Germany: Ethics Committee
Study ID:
AnPro
NCT ID:
NCT01448798
Start Date:
October 2011
Completion Date:
January 2014
Related Keywords:
- Prostate Cancer
- Erectile Dysfunction
- radical prostatectomy
- robotic surgery
- erectile dysfunction
- continence
- Prostatic Neoplasms
- Erectile Dysfunction