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

Study Overview
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Brief Summary
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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.

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

Conditions
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Prostate Cancer, Erectile Dysfunction

Intervention / Treatment
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* Procedure: Application of a hemostatic gelatin-thrombin matrix
* Procedure: Use of mono- and bipolar electrocautery and surgical clips


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gelatine-thrombin matrix<br>Nerves-paring during robotic-assisted laparoscopic prostatectomy is conducted without mono- or bipolar electrocautery and clipping by using a hemostatic gelatine-thrombin matrix. | Procedure: Application of a hemostatic gelatin-thrombin matrix<br>* Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.<br>|
| Sham Comparator: Control<br>Nerve-sparing during robotic-assisted radical prostatectomy is conducted with the use of mono- and bipolar electrocautery and surgical clipping. | Procedure: Use of mono- and bipolar electrocautery and surgical clips<br>* Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative erectile function | Postoperative erectile function compared to preoperative status assessed validated questionnaires. | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radical prostatectomy, robotic surgery, erectile dysfunction, continence