Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
NCT ID: NCT01770340
Last Updated: 2021-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
30 participants
INTERVENTIONAL
2011-01-31
2020-07-01
Brief Summary
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The investigators evaluate the use of the implantation of the allogenic nerve graft Avance® in patients undergoing non nerve-sparing radical prostatectomy.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Control group
Radical prostatectomy without implantation of allograft
Radical prostatectomy without implantation of allograft
No interposition of resected neurvascular bundles
Treatment group
Radical prostatectomy with implantation of allograft
Radical prostatectomy with implantation of allograft
Interposition of resected neurovascular bundles with allograft Avance®
Interventions
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Radical prostatectomy with implantation of allograft
Interposition of resected neurovascular bundles with allograft Avance®
Radical prostatectomy without implantation of allograft
No interposition of resected neurvascular bundles
Eligibility Criteria
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Inclusion Criteria
* Gleason score ≥ 7 (3+4 and/or 4+3) and/or
* PSA ≥ 20 ng/ml
* intact preoperative erectile function with an IIEF ≥ 21 (IIEF-6).
Exclusion Criteria
* Operations in the past 6 months which could limit the erectile function
* Erectile dysfunction in the history or current medication for erectile dysfunction
* Current involvement in another comparable study.
18 Years
MALE
No
Sponsors
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Kantonsspital Winterthur KSW
OTHER
Responsible Party
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Principal Investigators
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Hubert John, Chefarzt
Role: PRINCIPAL_INVESTIGATOR
Kantonsspital Winterthur KSW
Locations
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Kantonsspital Winterthur
Winterthur, Canton of Zurich, Switzerland
Countries
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Other Identifiers
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KEK-ZH-NR:2010-0004/0
Identifier Type: -
Identifier Source: org_study_id
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