- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01448798
Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix. (AnPro)
October 6, 2011 updated by: Axel Haferkamp, Johann Wolfgang Goethe University Hospital
Prospective Randomized Investigation of Athermal Nerve-sparing During Robotic-assisted Laparoscopic Prostatectomy Using a Hemostatic Gelatin-thrombin Matrix
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Axel Haferkamp, Prof.
- Phone Number: +49-69-6301-5352
- Email: axel.haferkamp@kgu.de
Study Contact Backup
- Name: Michael A Reiter, Dr.
- Phone Number: +49-69-6301-5352
- Email: michael.reiter@kgu.de
Study Locations
-
-
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Frankfurt/M., Germany, 60590
- Recruiting
- Johann Wolfgang Goethe University Hospital
-
Contact:
- Axel Haferkamp, Prof.
- Phone Number: +49-69-6301-5352
- Email: axel.haferkamp@kgu.de
-
Contact:
- Michael A Reiter, Dr.
- Phone Number: +49-69-6301-5352
- Email: michae.reiter@kgu.de
-
Sub-Investigator:
- Michael A Reiter, Dr.
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Principal Investigator:
- Axel Haferkamp, Prof.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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.
|
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.
|
Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative erectile function
Time Frame: 12 months
|
Postoperative erectile function compared to preoperative status assessed validated questionnaires.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative continence
Time Frame: 12 months
|
Postoperative continence compared to preoperative status assessed by validated questionnaires.
|
12 months
|
Intraoperative bloodloss
Time Frame: During surgery
|
Amount of blood collected in the suction during surgery.
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During surgery
|
Intra- and postoperative complications
Time Frame: Perioperative period
|
Intra- and postoperative complications associated to the study´s intervention.
|
Perioperative period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Axel Haferkamp, Prof., Johann Wolfgang Goethe University Hospitals, Germany
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Anticipated)
January 1, 2013
Study Completion (Anticipated)
January 1, 2014
Study Registration Dates
First Submitted
October 6, 2011
First Submitted That Met QC Criteria
October 6, 2011
First Posted (Estimate)
October 7, 2011
Study Record Updates
Last Update Posted (Estimate)
October 7, 2011
Last Update Submitted That Met QC Criteria
October 6, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AnPro
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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