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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by Axel Haferkamp, Johann Wolfgang Goethe University Hospitals.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01448798
First Posted: October 7, 2011
Last Update Posted: October 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Axel Haferkamp, Johann Wolfgang Goethe University Hospitals
  Purpose
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 Intervention
Prostate Cancer Erectile Dysfunction Procedure: Application of a hemostatic gelatin-thrombin matrix Procedure: Use of mono- and bipolar electrocautery and surgical clips

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Axel Haferkamp, Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Postoperative erectile function [ Time Frame: 12 months ]
    Postoperative erectile function compared to preoperative status assessed validated questionnaires.


Secondary Outcome Measures:
  • Postoperative continence [ Time Frame: 12 months ]
    Postoperative continence compared to preoperative status assessed by validated questionnaires.

  • Intraoperative bloodloss [ Time Frame: During surgery ]
    Amount of blood collected in the suction during surgery.

  • Intra- and postoperative complications [ Time Frame: Perioperative period ]
    Intra- and postoperative complications associated to the study´s intervention.


Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448798


Contacts
Contact: Axel Haferkamp, Prof. +49-69-6301-5352 axel.haferkamp@kgu.de
Contact: Michael A Reiter, Dr. +49-69-6301-5352 michael.reiter@kgu.de

Locations
Germany
Johann Wolfgang Goethe University Hospital Recruiting
Frankfurt/M., Germany, 60590
Contact: Axel Haferkamp, Prof.    +49-69-6301-5352    axel.haferkamp@kgu.de   
Contact: Michael A Reiter, Dr.    +49-69-6301-5352    michae.reiter@kgu.de   
Sub-Investigator: Michael A Reiter, Dr.         
Principal Investigator: Axel Haferkamp, Prof.         
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
Principal Investigator: Axel Haferkamp, Prof. Johann Wolfgang Goethe University Hospitals, Germany
  More Information

Responsible Party: Axel Haferkamp, Prof. Dr. med. Axel Haferkamp, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01448798     History of Changes
Other Study ID Numbers: AnPro
First Submitted: October 6, 2011
First Posted: October 7, 2011
Last Update Posted: October 7, 2011
Last Verified: October 2011

Keywords provided by Axel Haferkamp, Johann Wolfgang Goethe University Hospitals:
radical prostatectomy
robotic surgery
erectile dysfunction
continence

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Hemostatics
Thrombin
Coagulants