Clinical trial · Interventional
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
NCT01448798CI-TRIAL-00005601AnProunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Application of a hemostatic gelatin-thrombin matrix | Procedure | — | UNRESOLVED |
| Use of mono- and bipolar electrocautery and surgical clips | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- gelatine-thrombin matrix
- description
- Nerves-paring during robotic-assisted laparoscopic prostatectomy is conducted without mono- or bipolar electrocautery and clipping by using a hemostatic gelatine-thrombin matrix.
- interventionNames
- Procedure: Application of a hemostatic gelatin-thrombin matrix
- type
- SHAM_COMPARATOR
- label
- Control
- description
- Nerve-sparing during robotic-assisted radical prostatectomy is conducted with the use of mono- and bipolar electrocautery and surgical clipping.
- interventionNames
- Procedure: Use of mono- and bipolar electrocautery and surgical clips
Primary outcomes (1)
- measure
- Postoperative erectile function
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.