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

Prostate Cancer Clinical Trial

— AnPro  

Official title:

Prospective Randomized Investigation of Athermal Nerve-sparing During Robotic-assisted Laparoscopic Prostatectomy Using a Hemostatic Gelatin-thrombin Matrix

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01448798
• Other study ID #: AnPro
• Status: Recruiting
• Phase: N/A
• First received: October 6, 2011
• Last updated: October 6, 2011
• Start date: October 2011
• Est. completion date: January 2014

Study information

• Verified date: October 2011
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: Axel Haferkamp, Prof.
• Phone: +49-69-6301-5352
• Email: axel.haferkamp[@]kgu.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction
• Prostate Cancer

Intervention

Procedure:
• Application of a hemostatic gelatin-thrombin matrix
Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.
• 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.

Locations

Country	Name	City	State
Germany	Johann Wolfgang Goethe University Hospital	Frankfurt/M.

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative erectile function	Postoperative erectile function compared to preoperative status assessed validated questionnaires.	12 months	No
Secondary	Postoperative continence	Postoperative continence compared to preoperative status assessed by validated questionnaires.	12 months	No
Secondary	Intraoperative bloodloss	Amount of blood collected in the suction during surgery.	During surgery	Yes
Secondary	Intra- and postoperative complications	Intra- and postoperative complications associated to the study´s intervention.	Perioperative period	Yes