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Spots Global Cancer Trial Database for Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins

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Trial Identification

Brief Title: Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins

Official Title: Nerve-sparing, Robot-assisted Radical Prostatectomy Using a Personalized, 3D-printed Prostate Model for Selective Resection of Positive Surgical Margins

Study ID: NCT05960669

Conditions

Prostate Cancer

Study Description

Brief Summary: 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.

Detailed Description: 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Universitätsspital Basel Urologie, Basel, , Switzerland

Contact Details

Name: Christian CE Engesser, Dr.

Affiliation: University Hospital, Basel, Switzerland

Role: PRINCIPAL_INVESTIGATOR

Name: Jan JE Ebbing, PD Dr. med

Affiliation: University Hospital, Basel, Switzerland

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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