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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01448798

Acronym

AnPro

Enrollment

Registered

2011-10-07

Start date

2011-10-31

Completion date

2014-01-31

Last updated

2011-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction, Prostate Cancer

Keywords

radical prostatectomy, robotic surgery, erectile dysfunction, continence

Brief 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.

Interventions

PROCEDUREApplication of a hemostatic gelatin-thrombin matrix

Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.

PROCEDUREUse 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Postoperative erectile function	12 months	Postoperative erectile function compared to preoperative status assessed validated questionnaires.

Secondary

Measure	Time frame	Description
Postoperative continence	12 months	Postoperative continence compared to preoperative status assessed by validated questionnaires.
Intraoperative bloodloss	During surgery	Amount of blood collected in the suction during surgery.
Intra- and postoperative complications	Perioperative period	Intra- and postoperative complications associated to the study´s intervention.

Countries

Germany

Contacts

Primary ContactAxel Haferkamp, Prof.

axel.haferkamp@kgu.de+49-69-6301-5352

Backup ContactMichael A Reiter, Dr.

michael.reiter@kgu.de+49-69-6301-5352

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026