Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Control | Sham Comparator | Nerve-sparing during robotic-assisted radical prostatectomy is conducted with the use of mono- and bipolar electrocautery and surgical clipping. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Application of a hemostatic gelatin-thrombin matrix | Procedure | Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative erectile function | Postoperative erectile function compared to preoperative status assessed validated questionnaires. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative continence | Postoperative continence compared to preoperative status assessed by validated questionnaires. | 12 months |
| Intraoperative bloodloss | Amount of blood collected in the suction during surgery. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Axel Haferkamp, Prof. | Contact | +49-69-6301-5352 | axel.haferkamp@kgu.de | |
| Michael A Reiter, Dr. | Contact | +49-69-6301-5352 | michael.reiter@kgu.de |
| Name | Affiliation | Role |
|---|---|---|
| Axel Haferkamp, Prof. | Johann Wolfgang Goethe University Hospitals, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johann Wolfgang Goethe University Hospital | Recruiting | Frankfurt/M. | 60590 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
| Use of mono- and bipolar electrocautery and surgical clips | Procedure | Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate. |
|
| During surgery |
| Intra- and postoperative complications | Intra- and postoperative complications associated to the study´s intervention. | Perioperative period |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
Not provided
Not provided