Effect of Peritoneal Fixation on Lymphocele Formation

Not Applicable

Completed

• Conditions: Prostate Cancer; Lymphocele After Surgical Procedure
• Interventions: Procedure: Peritoneal fixation (PerFix); Procedure: Standard of care

• Registration Number: NCT04853095
• Lead Sponsor: University Hospital Olomouc

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.

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2021-02-28
• Study First Submitted QC: 2021-04-19
• Study First Posted: 2021-04-21
• Primary Completion: 2021-12-31
• Study Completion: 2022-01-01
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-15
• Last Update Posted: 2022-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 260

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group (PerFix)	Peritoneal fixation (PerFix)	Peritoneal fixation technique
Control group (no PerFix)	Standard of care	Standard of care (i.e. no fixation)

Primary Outcome Measures

Name	Time	Method
Number of participants with Symptomatic lymphocele	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 Outcome Measures

Name	Time	Method
Rate of severe (Clavien grade ≥3) complications	3 months	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
Change in lymphocele size	1 year	The change in lymphocele size during follow-up CT scan will be examined
The effect of lymphocele on urinary incontinence	1 year	The rate of continent patients will be defined using pads needed per day. Continent equals to 0-1 pad per day.
The effect of lymphocele on potency	1 year	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.
Perioperative outcomes	30 days	Perioperative outcomes (time of the surgery, blood loss and hospital stay) will be measured
Number of participants with Radiologic lymphocele on pelvic CT scan	3 months	The number of participants with radiologic lymphocele on Pelvic CT scan will be determined together with the size, location and number of detected lymphoceles.
Number of participants with Occurrence of Any Venous Thromboembolism	6 months	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
The effect of lymphocele on lower urinary tract symptoms (LUTS)	1 year	Change in the International prostate symptom score (IPSS) questionnaire from the baseline will be assessed (scale 0-35, higher score means worse outcome).

Trial Locations

Locations (1)

University hospital Olomouc; 🇨🇿 Olomouc, Czechia