Skip to main content
OpenTrials
Completed

NCT Number: NCT04853095

Effect of Peritoneal Fixation on Lymphocele Formation

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peritoneal fixation (PerFix)

Procedure

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.

Standard of care

Procedure

ePLND without peritoneal flap fixation

Primary outcomes

  1. 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

  1. Number of participants with Radiologic lymphocele on pelvic CT scan

    Time frame: 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.

  2. Rate of severe (Clavien grade ≥3) complications

    Time frame: 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

  3. Change in lymphocele size

    Time frame: 1 year

    The change in lymphocele size during follow-up CT scan will be examined

  4. Number of participants with Occurrence of Any Venous Thromboembolism

    Time frame: 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

  5. Perioperative outcomes

    Time frame: 30 days

    Perioperative outcomes (time of the surgery, blood loss and hospital stay) will be measured

  6. The effect of lymphocele on urinary incontinence

    Time frame: 1 year

    The rate of continent patients will be defined using pads needed per day. Continent equals to 0-1 pad per day.

  7. The effect of lymphocele on potency

    Time frame: 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.

  8. The effect of lymphocele on lower urinary tract symptoms (LUTS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University Hospital Olomouc

Other

Registry information

Official study 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)

Acronym: PerFix

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Apr 21, 2021
Registry last updated
Dec 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.