Status:
COMPLETED
Effect of Peritoneal Fixation on Lymphocele Formation
Lead Sponsor:
University Hospital Olomouc
Conditions:
Prostate Cancer
Lymphocele After Surgical Procedure
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The PerFix Trial aims to compare the use of peritoneal fixation technique to standard of care (no fixation) during robot-assisted radical prostatectomy with extended pelvic lymph node dissection (RARP...
Detailed Description
Extended pelvic lymph node dissection (ePLND) is the most accurate staging tool to determine lymph node involvement in prostate cancer. As urologist perform this procedure more often now, thanks to th...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Able to give informed consent
- Histologically proven high risk prostate cancer or intermediate risk cancer (≥5% risk of nodal involvement on Briganti 2012 nomogram) according to European Association od Urology (EAU) risk groups
- Suitable for minimally-invasive surgery
Exclusion
- Previous pelvic surgery or irradiation.
- Any type of clotting disorder.
- Patients unwilling to undergo CT scan
- Kidney failure, Hemodialysis
- American Society of Anesthesiology Classification\> 3
- Existing contraindications for performing a lymph node dissection
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04853095
Start Date
December 1 2019
End Date
January 1 2022
Last Update
December 16 2022
Active Locations (1)
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1
University hospital Olomouc
Olomouc, Czechia, 77900