Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix. (AnPro)

Johann Wolfgang Goethe University Hospital

Status: Unknown

Conditions: Erectile Dysfunction; Prostate Cancer

Treatments: Procedure: Application of a hemostatic gelatin-thrombin matrix; Procedure: Use of mono- and bipolar electrocautery and surgical clips

Study type: Interventional

Funder types: Other

Identifiers

NCT01448798

AnPro

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

gelatine-thrombin matrix

Experimental group

Description:

Nerves-paring during robotic-assisted laparoscopic prostatectomy is conducted without mono- or bipolar electrocautery and clipping by using a hemostatic gelatine-thrombin matrix.

Treatment:

Procedure: Application of a hemostatic gelatin-thrombin matrix

Control

Sham Comparator group

Description:

Nerve-sparing during robotic-assisted radical prostatectomy is conducted with the use of mono- and bipolar electrocautery and surgical clipping.

Treatment:

Procedure: Use of mono- and bipolar electrocautery and surgical clips