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Prospective Randomized Investigation of Athermal Nerve-sparing During Robotic-assisted Laparoscopic Prostatectomy Using a Hemostatic Gelatin-thrombin Matrix


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer, Erectile Dysfunction

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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

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