CClinicalTrials.gg
Status unknownNCT01448798AnProUpdated Oct 7, 2011

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

An interventional study of Application of a hemostatic gelatin-thrombin matrix and Use of mono- and bipolar electrocautery and surgical clips in Prostate Cancer and Erectile Dysfunction, sponsored by Johann Wolfgang Goethe University Hospital. Status unknown at 1 site in Germany. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-07.

Sponsored by Johann Wolfgang Goethe University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
Male
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Study 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.

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Conditions studied

  • Prostate Cancer
  • Erectile Dysfunction

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Keywords

  • radical prostatectomy
  • robotic surgery
  • erectile dysfunction
  • continence
03

In context

Erectile Dysfunction

683 studies on the registry are indexed under Erectile Dysfunction; 116 are open to participants now.

This study's planned enrollment of 50 is below the median of 72 across 541 interventional studies indexed under Erectile Dysfunction.

Browse Erectile Dysfunction studies →

Lead sponsor

Johann Wolfgang Goethe University Hospital is the lead sponsor of 158 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
50 participants (estimated)

Study arms

  • 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

  • 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

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.

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What researchers measure

Primary outcomes

  1. Postoperative erectile function

    Postoperative erectile function compared to preoperative status assessed validated questionnaires.

    Time frame: 12 months

Secondary outcomes

  1. Postoperative continence

    Postoperative continence compared to preoperative status assessed by validated questionnaires.

    Time frame: 12 months

  2. Intraoperative bloodloss

    Amount of blood collected in the suction during surgery.

    Time frame: During surgery

  3. Intra- and postoperative complications

    Intra- and postoperative complications associated to the study´s intervention.

    Time frame: Perioperative period

07

Study locations

1 of 1 sites recruiting
  • Johann Wolfgang Goethe University Hospital
    Frankfurt/M., 60590, Germany
    • Axel Haferkamp, Prof. · Contact · axel.haferkamp@kgu.de · +49-69-6301-5352
    • Michael A Reiter, Dr. · Contact · michae.reiter@kgu.de · +49-69-6301-5352
    • Michael A Reiter, Dr. · Sub investigator
    • Axel Haferkamp, Prof. · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01448798
Lead sponsor
Johann Wolfgang Goethe University Hospital
Responsible party
Axel Haferkamp (Prof. Dr. med. Axel Haferkamp, Johann Wolfgang Goethe University Hospital) — Principal investigator
First posted
Oct 7, 2011
Start date
Oct 2011
Primary completion
Jan 2013 (estimated)
Completion
Jan 2014 (estimated)
Last update
Oct 7, 2011

Study contacts

Axel Haferkamp, Prof.
Contact
axel.haferkamp@kgu.de
+49-69-6301-5352
Michael A Reiter, Dr.
Contact
michael.reiter@kgu.de
+49-69-6301-5352
Axel Haferkamp, Prof.
principal investigator · Johann Wolfgang Goethe University Hospitals, Germany

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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