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

Primary Purpose

Prostate Cancer, Erectile Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Application of a hemostatic gelatin-thrombin matrix
Use of mono- and bipolar electrocautery and surgical clips
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring radical prostatectomy, robotic surgery, erectile dysfunction, continence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

  • Johann Wolfgang Goethe University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

gelatine-thrombin matrix

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative erectile function
Postoperative erectile function compared to preoperative status assessed validated questionnaires.

Secondary Outcome Measures

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

Full Information

First Posted
October 6, 2011
Last Updated
October 6, 2011
Sponsor
Johann Wolfgang Goethe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01448798
Brief Title
Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix.
Acronym
AnPro
Official Title
Prospective Randomized Investigation of Athermal Nerve-sparing During Robotic-assisted Laparoscopic Prostatectomy Using a Hemostatic Gelatin-thrombin Matrix
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Erectile Dysfunction
Keywords
radical prostatectomy, robotic surgery, erectile dysfunction, continence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
gelatine-thrombin matrix
Arm Type
Experimental
Arm Description
Nerves-paring during robotic-assisted laparoscopic prostatectomy is conducted without mono- or bipolar electrocautery and clipping by using a hemostatic gelatine-thrombin matrix.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Nerve-sparing during robotic-assisted radical prostatectomy is conducted with the use of mono- and bipolar electrocautery and surgical clipping.
Intervention Type
Procedure
Intervention Name(s)
Application of a hemostatic gelatin-thrombin matrix
Intervention Description
Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.
Intervention Type
Procedure
Intervention Name(s)
Use of mono- and bipolar electrocautery and surgical clips
Intervention Description
Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate.
Primary Outcome Measure Information:
Title
Postoperative erectile function
Description
Postoperative erectile function compared to preoperative status assessed validated questionnaires.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Postoperative continence
Description
Postoperative continence compared to preoperative status assessed by validated questionnaires.
Time Frame
12 months
Title
Intraoperative bloodloss
Description
Amount of blood collected in the suction during surgery.
Time Frame
During surgery
Title
Intra- and postoperative complications
Description
Intra- and postoperative complications associated to the study´s intervention.
Time Frame
Perioperative period

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Axel Haferkamp, Prof.
Phone
+49-69-6301-5352
Email
axel.haferkamp@kgu.de
First Name & Middle Initial & Last Name or Official Title & Degree
Michael A Reiter, Dr.
Phone
+49-69-6301-5352
Email
michael.reiter@kgu.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Axel Haferkamp, Prof.
Organizational Affiliation
Johann Wolfgang Goethe University Hospitals, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johann Wolfgang Goethe University Hospital
City
Frankfurt/M.
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Axel Haferkamp, Prof.
Phone
+49-69-6301-5352
Email
axel.haferkamp@kgu.de
First Name & Middle Initial & Last Name & Degree
Michael A Reiter, Dr.
Phone
+49-69-6301-5352
Email
michae.reiter@kgu.de
First Name & Middle Initial & Last Name & Degree
Michael A Reiter, Dr.
First Name & Middle Initial & Last Name & Degree
Axel Haferkamp, Prof.

12. IPD Sharing Statement

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

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