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

Sponsor

Johann Wolfgang Goethe University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01448798

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Erectile Dysfunction	Procedure: Application of a hemostatic gelatin-thrombin matrix Procedure: Use of mono- and bipolar electrocautery and surgical clips	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2013

Anticipated Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: gelatine-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.	Procedure: Application of a hemostatic gelatin-thrombin matrix Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.
Sham Comparator: Control 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 Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate.

Arm

Intervention/Treatment

Experimental: gelatine-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.

Procedure: Application of a hemostatic gelatin-thrombin matrix

Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.

Sham Comparator: Control

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

Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate.

Outcome Measures

Primary Outcome Measures

Postoperative erectile function [12 months]
Postoperative erectile function compared to preoperative status assessed validated questionnaires.

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Johann Wolfgang Goethe University Hospital	Frankfurt/M.		Germany	60590

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospital

Investigators

Principal Investigator: Axel Haferkamp, Prof., Johann Wolfgang Goethe University Hospitals, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Axel Haferkamp, Prof. Dr. med. Axel Haferkamp, Johann Wolfgang Goethe University Hospital

ClinicalTrials.gov Identifier:

NCT01448798

Other Study ID Numbers:

AnPro

First Posted:

Oct 7, 2011

Last Update Posted:

Oct 7, 2011

Last Verified:

Oct 1, 2011

Keywords provided by Axel Haferkamp, Prof. Dr. med. Axel Haferkamp, Johann Wolfgang Goethe University Hospital

radical prostatectomy

robotic surgery

erectile dysfunction

continence

Additional relevant MeSH terms:

Erectile Dysfunction

Thrombin

Hemostatics

Study Results

No Results Posted as of Oct 7, 2011