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Resect SAFE study: providing a reliable impression of the positive surgical margin in patients undergoing robot assisted radical prostatectomy for prostate cancer

Resect SAFE study: providing a reliable impression of the positive surgical margin in patients undergoing robot assisted radical prostatectomy for prostate cancer - Resect SAFE study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56573
Enrollment
160
Registered
2024-02-08
Start date
2024-04-22
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer

Interventions

During the prostatectomy, subsequent to the prostate removal and achieving satisfactory hemostasis, abundant tissue is excised on the non-nerve-sparing side(s) surrounding the area previously occupi

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Undergoing a non-nerve-sparing robot assisted laparoscopic radical prostatectomy (unilateral or bilateral non-nerve-sparing). Any value of prostate-specific antigen (PSA). Any grade from the International Society of Urological Pathology (ISUP). Any tumor (T) stage on the magnetic resonance imaging (MRI) scan.

Exclusion criteria

Exclusion criteria: Molecular Imaging (MI), specifically on PSMA-PET, a lymph node (N) stage 1 Salvage prostatectomy NeuroSAFE procedure.

Design outcomes

Primary

MeasureTime frame
The count of positive surgical margins among patients undergoing RARP for prostate cancer, wherein exision of abundant tissue was conducted during the RARP procedure.

Secondary

MeasureTime frame
- To evaluate the incidence of complications (rectal injury and postoperative bleeding) among patients who have undergone the Resect SAFE procedure. - To determine the rate of biochemical recurrence (at 6 months and 1 year) within the cohort of patients subjected to the Resect SAFE procedure

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)