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To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model.
Background: Nerve-sparing (NS) robot-assisted radical prostatectomy (RARP) offers optimized oncological and functional outcomes and has become the preferred minimally-invasive approach when available. To maximize oncologic safety in NS-RARP, a frozen section (FS) can be used but does not provide a visual impression of the positive surgical margin (PSM) to guide secondary resection (SR). Objective: To optimize precision for secondary resection (SR) in frozen section (FS) controlled nerve-sparing robot-assisted radical prostatectomy (NS-RARP) by using a personalized 3D-printed prostate model. Design, setting and participants: 100 patients with NS-RARP performed between September 2018 and August 2021 were included in this prospective multicenter cohort study. Interventions: A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a PSM and guide SR. Outcome Measurements and statistical analysis Endpoints were comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status. Secondary parameters for oncological and erectile outcomes were assessed before and one year after surgery.
Age
18 - 80 years
Sex
MALE
Healthy Volunteers
No
Universitätsspital Basel Urologie
Basel, Switzerland
Start Date
August 1, 2018
Primary Completion Date
August 26, 2021
Completion Date
August 26, 2022
Last Updated
July 27, 2023
100
ACTUAL participants
3D model guided secondary resection
PROCEDURE
Lead Sponsor
University Hospital, Basel, Switzerland
Collaborators
NCT05691465
NCT06842498
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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View ClinicalTrials.gov Terms and ConditionsNCT04550494