Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
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|ClinicalTrials.gov Identifier: NCT01770340|
Recruitment Status : Active, not recruiting
First Posted : January 17, 2013
Last Update Posted : November 5, 2019
Earlier studies were able to show that an improvement of the erectile function following a non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft.
The investigators evaluate the use of the implantation of the allogenic nerve graft Avance® in patients undergoing non nerve-sparing radical prostatectomy.
|Condition or disease||Intervention/treatment||Phase|
|Erectile Dysfunction Following Radical Prostatectomy||Biological: Radical prostatectomy with implantation of allograft Procedure: Radical prostatectomy without implantation of allograft||Phase 4|
In this prospective randomised and single-blind, clinical phase-IV study, 60 patients are randomized into the treatment group and the control group. The follow-up is at least 24 months.
The inclusion criteria were localized prostate cancers cT3 and/or Gleason score ≥ 7 (a or b) and/or prostate-specific antigen (PSA) ≥ 20 ng/ml and furthermore an erectile function with an IIEF ≥ 21 (IIEF-6).
The operation carried out is a standardised, robot assisted laparoscopic radical prostatectomy with total excision of both neurovascular bundles.
The Outcome measurement is done with the "quality of life questionnaire before and after prostate surgery" that includes the "International Index of Erectile Function" (IIEF) questionnaire.
The limitations are a small cohort, a short observation period and the lack of statistical analysis due to a still low number of patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||April 2017|
|Estimated Study Completion Date :||July 2020|
Sham Comparator: Control group
Radical prostatectomy without implantation of allograft
Procedure: Radical prostatectomy without implantation of allograft
No interposition of resected neurvascular bundles
Experimental: Treatment group
Radical prostatectomy with implantation of allograft
Biological: Radical prostatectomy with implantation of allograft
Interposition of resected neurovascular bundles with allograft Avance®
- Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy [ Time Frame: 24 months ]Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy. To show a complete impotence in the control group and an enhancement of the initial postoperative impotence in the treatment group
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 months ]Monitoring of side effects and complications in connection with the nerve-implantation.
- Documented will be the extra time required for the nerve implantation [ Time Frame: at the time of operation ]How much operation-time takes the nerve implantation? The time is stopped which is required for the implantation of the nerve. Start is when the prostate was removed and was deposited in the extraction bag. Stop when the anastomosis of the nerves is stitched and the anastomosis of the urethra begins.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01770340
|Winterthur, Kanton Zürich, Switzerland, 8401|
|Principal Investigator:||Hubert John, Chefarzt||Kantonsspital Winterthur KSW|