Prospective Randomized Trial Evaluating the Effect of Peritoneal Flap Fixation on Symptomatic and Radiologic Lymphocele Formation Following Robot Assisted Radical Prostatectomy With Extended Pelvic Lymph Node Dissection (PerFix)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University Hospital Olomouc
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Number of participants with Symptomatic lymphocele
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 + eLND) for the prevention of symptomatic and radiologic lymphocele formation.
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 the shift to more advanced and aggressive stages, the role of ePLND is expanding. The main complication of PLND is development of a collection of lymphatic fluid called a lymphocele. Lymphoceles can be associated with abdominal pain, lower urinary tract symptoms, bladder outlet obstruction, penile or scrotal edema, infection/sepsis, lower extremity swelling and deep vein thrombosis. They necessitate intervention in up to 10% of patients treated with RARP + ePLND which includes drainage or surgery. Radiologic incidence can be as high as around 50% of operated patients with unknown clinical relevance. Many interventions aimed at reducing the rate of lymphocele formation with limited success so far. Several retrospective studies suggested using peritoneal flap fixation technique which could direct the lymphatic fluid to the peritoneal cavity out of the pelvis and its ensure its reabsorption there. We hypothesize that peritoneal fixation can potentially lower the incidence of symptomatic and radiologic lymphocele formation. By preventing this potentially very dangerous complication, it could be very beneficial for a large group of patients suffering from aggressive localized prostate cancer who are scheduled for RARP + ePLND. Our goal is to is to test this hypothesis in a randomized trial comparing the fixation technique to standard of care, i.e. no fixation.
Investigators
Vladimir Student, M.D., Ph.D.
Vladimir Student Jr., MD, PhD, FEBU
University Hospital Olomouc
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Outcomes
Primary Outcomes
Number of participants with Symptomatic lymphocele
Time Frame: 3 months
The number of participants with symptomatic lymphocele will be determined. Clinical symptoms, time of onset, the size of the lymphocele, location, number of Lymphoceles and intervention needed will be measured
Secondary Outcomes
- Rate of severe (Clavien grade ≥3) complications(3 months)
- Change in lymphocele size(1 year)
- The effect of lymphocele on urinary incontinence(1 year)
- The effect of lymphocele on potency(1 year)
- Perioperative outcomes(30 days)
- Number of participants with Radiologic lymphocele on pelvic CT scan(3 months)
- Number of participants with Occurrence of Any Venous Thromboembolism(6 months)
- The effect of lymphocele on lower urinary tract symptoms (LUTS)(1 year)