Athermal Nerve-sparing During Robotic-assisted Radical Prostatectomy Using a Hemostatic Matrix. (AnPro)
|ClinicalTrials.gov Identifier: NCT01448798|
Recruitment Status : Unknown
Verified October 2011 by Axel Haferkamp, Johann Wolfgang Goethe University Hospital.
Recruitment status was: Recruiting
First Posted : October 7, 2011
Last Update Posted : October 7, 2011
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Erectile Dysfunction||Procedure: Application of a hemostatic gelatin-thrombin matrix Procedure: Use of mono- and bipolar electrocautery and surgical clips||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Prospective Randomized Investigation of Athermal Nerve-sparing During Robotic-assisted Laparoscopic Prostatectomy Using a Hemostatic Gelatin-thrombin Matrix|
|Study Start Date :||October 2011|
|Estimated Primary Completion Date :||January 2013|
|Estimated Study Completion Date :||January 2014|
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.
- Postoperative erectile function [ Time Frame: 12 months ]Postoperative erectile function compared to preoperative status assessed validated questionnaires.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01448798
|Contact: Axel Haferkamp, Prof.||+firstname.lastname@example.org|
|Contact: Michael A Reiter, Dr.||+email@example.com|
|Johann Wolfgang Goethe University Hospital||Recruiting|
|Frankfurt/M., Germany, 60590|
|Contact: Axel Haferkamp, Prof. +49-69-6301-5352 firstname.lastname@example.org|
|Contact: Michael A Reiter, Dr. +49-69-6301-5352 email@example.com|
|Sub-Investigator: Michael A Reiter, Dr.|
|Principal Investigator: Axel Haferkamp, Prof.|
|Principal Investigator:||Axel Haferkamp, Prof.||Johann Wolfgang Goethe University Hospitals, Germany|