Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Axel Haferkamp, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01448798
First received: October 6, 2011
Last updated: NA
Last verified: October 2011
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Postoperative erectile function [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Postoperative erectile function compared to preoperative status assessed validated questionnaires.


Secondary Outcome Measures:
  • Postoperative continence [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Postoperative continence compared to preoperative status assessed by validated questionnaires.

  • Intraoperative bloodloss [ Time Frame: During surgery ] [ Designated as safety issue: Yes ]
    Amount of blood collected in the suction during surgery.

  • Intra- and postoperative complications [ Time Frame: Perioperative period ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Hospitals
Investigators
Principal Investigator: Axel Haferkamp, Prof. Johann Wolfgang Goethe University Hospitals, Germany
  More Information

No publications provided

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
Study First Received: October 6, 2011
Last Updated: October 6, 2011
Health Authority: Germany: Ethics Committee

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

Additional relevant MeSH terms:
Erectile Dysfunction
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Mental Disorders
Neoplasms
Neoplasms by Site
Prostatic Diseases
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Urogenital Neoplasms
Hemostatics
Thrombin
Coagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014