Prostate CancerAnProNCT01448798
Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix.
A study testing Application of a hemostatic gelatin-thrombin matrix and Use of mono- and bipolar electrocautery and surgical clips in people with Prostate Cancer and Erectile Dysfunction, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Erectile Dysfunction
- What is being tested?
- Application of a hemostatic gelatin-thrombin matrix and Use of mono- and bipolar electrocautery and surgical clips
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- ASA IV-V
- Prior extensive abdominal surgery
- Signs for metastatic disease
- Known allergy against bovine material
- Patient is unable to give informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Johann Wolfgang Goethe University Hospital
Frankfurt/M., 60590
Axel Haferkamp, Prof., +49-69-6301-5352, axel.haferkamp@kgu.de
Michael A Reiter, Dr., +49-69-6301-5352, michae.reiter@kgu.de
About this study
Official title: 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.
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Being tested
- Application of a hemostatic gelatin-thrombin matrix, Use of mono- and bipolar electrocautery and surgical clips
- Keywords
- radical prostatectomy, robotic surgery, erectile dysfunction, continence
- Medical subject headings
- Prostatic Neoplasms, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of a hemostatic gelatin-thrombin matrixProcedure or surgery
Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.
Use of mono- and bipolar electrocautery and surgical clipsProcedure or surgery
Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate.
| Study group | Role | What they receive |
|---|---|---|
| gelatine-thrombin matrix | Experimental | Nerves-paring during robotic-assisted laparoscopic prostatectomy is conducted without mono- or bipolar electrocautery and clipping by using a hemostatic gelatine-thrombin matrix. Receives: Procedure: Application of a hemostatic gelatin-thrombin matrix |
| Control | Sham comparator | Nerve-sparing during robotic-assisted radical prostatectomy is conducted with the use of mono- and bipolar electrocautery and surgical clipping. Receives: Procedure: Use of mono- and bipolar electrocautery and surgical clips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative erectile function
Postoperative erectile function compared to preoperative status assessed validated questionnaires.
Measured: 12 months
Secondary outcomes (3)
Postoperative continence
Postoperative continence compared to preoperative status assessed by validated questionnaires.
Measured: 12 months
Intraoperative bloodloss
Amount of blood collected in the suction during surgery.
Measured: During surgery
Intra- and postoperative complications
Intra- and postoperative complications associated to the study´s intervention.
Measured: Perioperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Axel Haferkamp, Johann Wolfgang Goethe University Hospital
- Investigators
- Axel Haferkamp, Prof., Principal investigator, Johann Wolfgang Goethe University Hospitals, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448798
- Sponsor's protocol ID
- AnPro
- Acronym
- AnPro
- Status last verified
- Oct 2011
- First submitted
- 6 Oct 2011
- Last updated
- 7 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Investigation of Athermal Nerve-sparing During Robotic-assisted Laparoscopic Prostatectomy Using a Hemostatic Gelatin-thrombin Matrix
- ClinicalTrials.gov ID
- NCT01448798
- Acronym / sponsor ID
- AnPro / AnPro
- Conditions
- Prostate Cancer, Erectile Dysfunction
- Keywords
- radical prostatectomy, robotic surgery, erectile dysfunction, continence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gelatine-thrombin matrix | Experimental | Procedure: Application of a hemostatic gelatin-thrombin matrixNerves-paring during robotic-assisted laparoscopic prostatectomy is conducted without mono- or bipolar electrocautery and clipping by using a hemostatic gelatine-thrombin matrix. |
| Control | Sham comparator | Procedure: Use of mono- and bipolar electrocautery and surgical clipsNerve-sparing during robotic-assisted radical prostatectomy is conducted with the use of mono- and bipolar electrocautery and surgical clipping. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- ASA IV-V
- Prior extensive abdominal surgery
- Signs for metastatic disease
- Known allergy against bovine material
- Patient is unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of a hemostatic gelatin-thrombin matrixHemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate. | Procedure or surgery | gelatine-thrombin matrix |
| Use of mono- and bipolar electrocautery and surgical clipsMono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate. | Procedure or surgery | Control |
Primary outcome
Postoperative erectile function
Time frame: 12 months
Postoperative erectile function compared to preoperative status assessed validated questionnaires.
3 secondary outcomes
Postoperative continence
Time frame: 12 months
Intraoperative bloodloss
Time frame: During surgery
Intra- and postoperative complications
Time frame: Perioperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Haferkamp, Prof. principal investigator
Johann Wolfgang Goethe University Hospitals, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of a hemostatic gelatin-thrombin matrix and Use of mono- and bipolar electrocautery and surgical clips in people with Prostate Cancer and Erectile Dysfunction, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Axel Haferkamp, Prof. (+49-69-6301-5352, axel.haferkamp@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative erectile function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2011.