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

Not Applicable

• Conditions: Prostate Cancer; Erectile Dysfunction
• Interventions: Procedure: Application of a hemostatic gelatin-thrombin matrix; Procedure: Use of mono- and bipolar electrocautery and surgical clips

• Registration Number: NCT01448798
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-10
• Study Start: 2011-10
• Study First Submitted: 2011-10-06
• Study First Submitted QC: 2011-10-06
• Last Update Submitted: 2011-10-06
• Study First Posted: 2011-10-07
• Last Update Posted: 2011-10-07
• Primary Completion: 2013-01
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gelatine-thrombin matrix	Application of a hemostatic gelatin-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.
Control	Use of mono- and bipolar electrocautery and surgical clips	Nerve-sparing during robotic-assisted radical prostatectomy is conducted with the use of mono- and bipolar electrocautery and surgical clipping.

Primary Outcome Measures

Name	Time	Method
Postoperative erectile function	12 months	Postoperative erectile function compared to preoperative status assessed validated questionnaires.

Secondary Outcome Measures

Name	Time	Method
Postoperative continence	12 months	Postoperative continence compared to preoperative status assessed by validated questionnaires.
Intraoperative bloodloss	During surgery	Amount of blood collected in the suction during surgery.
Intra- and postoperative complications	Perioperative period	Intra- and postoperative complications associated to the study´s intervention.

Trial Locations

Locations (1)

Johann Wolfgang Goethe University Hospital; 🇩🇪 Frankfurt/M., Germany