Effect of Peritoneal Fixation on Lymphocele Formation (PerFix)

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)

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Lymphocele After Surgical Procedure
• Intervention / Treatment: Procedure: Peritoneal fixation (PerFix); Procedure: Standard of care

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.

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Olomouc, Czechia, 77900
    • University Hospital Olomouc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group (PerFix); Peritoneal fixation technique	Procedure: Peritoneal fixation (PerFix); PerFix involves suturing the free end of the peritoneal flap left after RARP + ePLND to the pelvic wall near the symphysis of the pubic bones leaving two lateral openings for directing the lymphatic fluid out of the pelvis to the abdominal cavity.
Active Comparator: Control group (no PerFix); Standard of care (i.e. no fixation)	Procedure: Standard of care; ePLND without peritoneal flap fixation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Symptomatic lymphocele	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	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Radiologic lymphocele on pelvic CT scan	The number of participants with radiologic lymphocele on Pelvic CT scan will be determined together with the size, location and number of detected lymphoceles.	3 months
Rate of severe (Clavien grade ≥3) complications	Incidence of adverse events in the Prefix group compared to control group (no PerFix) will be measured. Surgical complications will be evaluated according to Clavien-Dindo classification	3 months
Change in lymphocele size	The change in lymphocele size during follow-up CT scan will be examined	1 year
Number of participants with Occurrence of Any Venous Thromboembolism	Radiologic investigation will be done in case of by swelling or pain of the lower extremity and the number of any venous thromboembolism will be determined	6 months
Perioperative outcomes	Perioperative outcomes (time of the surgery, blood loss and hospital stay) will be measured	30 days
The effect of lymphocele on urinary incontinence	The rate of continent patients will be defined using pads needed per day. Continent equals to 0-1 pad per day.	1 year
The effect of lymphocele on potency	Potency equals to 19 and more points in the International index of erectile function (IIEF5) questionnaire (scale 0-25), the higher the score, the better.	1 year
The effect of lymphocele on lower urinary tract symptoms (LUTS)	Change in the International prostate symptom score (IPSS) questionnaire from the baseline will be assessed (scale 0-35, higher score means worse outcome).	1 year

Collaborators and Investigators

• Sponsor: University Hospital Olomouc
• Investigators: Principal Investigator: Vladimir Student, MD, PhD, Dpt. of Urology

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: February 28, 2021
• First Submitted That Met QC Criteria: April 19, 2021
• First Posted (Actual): April 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Prostate cancer; Extended pelvic lymph node dissection; Lymphocele; Robot-assisted radical prostatectomy; Peritoneal fixation; Lymphatic disease
• Additional Relevant MeSH Terms: Neoplasms; Lymphatic Diseases; Urogenital Neoplasms; Neoplasms by Site; Cysts; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Lymphocele
• Other Study ID Numbers: FNOl 00098892

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No