Effect of Peritoneal Fixation on Lymphocele Formation (PerFix)

University Hospital Olomouc

Status: Completed

Conditions: Lymphocele After Surgical Procedure; Prostate Cancer

Treatments: Procedure: Peritoneal fixation (PerFix); Procedure: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT04853095

FNOl 00098892

Details and patient eligibility

About

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.

Full 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.

Enrollment: 260 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 2 patient groups

Intervention group (PerFix)

Experimental group

Description:

Peritoneal fixation technique

Treatment:

Procedure: Peritoneal fixation (PerFix)

Control group (no PerFix)

Active Comparator group

Description:

Standard of care (i.e. no fixation)

Treatment:

Procedure: Standard of care