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| Name | Class |
|---|---|
| Intuitive Surgical | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D model guided SR | Experimental | A prostate model was 3D printed from preoperative pelvic MRI data and used during surgery to mark a positive surgical margin and guide secondary resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D model guided secondary resection | Procedure | A prostate model was 3D printed from preoperative pelvic MRI data and used during robot-assisted radical prostatectomy to mark a positive surgical margin and guide secondary resection. |
| Measure | Description | Time Frame |
|---|---|---|
| comparison of the primary surgical margin status in the FS with the tissue of the resulting SR and with the final surgical margin status | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Erectile function | IIEF-5 | 1 year |
| Oncologic follow-up | PSA Monitoring | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian CE Engesser, Dr. | University Hospital, Basel, Switzerland | Principal Investigator |
| Jan JE Ebbing, PD Dr. med | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsspital Basel Urologie | Basel | 4031 | Switzerland |
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Cohort Study
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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