Clinical trial NCT04853095: Effect of Peritoneal Fixation on Lymphocele Formation
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lymphocele After Surgical Procedure
Keywords: Prostate cancer
Robot-assisted radical prostatectomy
Extended pelvic lymph node dissection
Lymphocele
Peritoneal fixation
Lymphatic disease
Lead sponsor: University Hospital Olomouc
Sponsor class: OTHER
First posted: 2021-04-21
Enrollment: 260
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants with Symptomatic lymphocele
timeFrame: 3 months
Secondary outcomes:
measure: Number of participants with Radiologic lymphocele on pelvic CT scan
timeFrame: 3 months
measure: Rate of severe (Clavien grade ≥3) complications
timeFrame: 3 months
measure: Change in lymphocele size
timeFrame: 1 year
measure: Number of participants with Occurrence of Any Venous Thromboembolism
timeFrame: 6 months
measure: Perioperative outcomes
timeFrame: 30 days
measure: The effect of lymphocele on urinary incontinence
timeFrame: 1 year
measure: The effect of lymphocele on potency
timeFrame: 1 year
measure: The effect of lymphocele on lower urinary tract symptoms (LUTS)
timeFrame: 1 year
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University hospital Olomouc
Study officials:
affiliation: Dpt. of Urology
name: Vladimir Student, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: