Effect of Peritoneal Fixation on Lymphocele Formation (PerFix)

• ClinicalTrials.gov Identifier: NCT04853095
• Recruitment Status: Recruiting
• First Posted: April 21, 2021
• Last Update Posted: February 23, 2022
• Sponsor: University Hospital Olomouc
• Information provided by (Responsible Party): Vladimir Student, M.D., Ph.D., University Hospital Olomouc

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer; Lymphocele After Surgical Procedure	Procedure: Peritoneal fixation (PerFix); Procedure: Standard of care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: December 1, 2019
• Actual Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: March 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Vladimir Student Jr., MD, PhD; +420737807881; vladastudent@gmail.com

Contact: Vladimir Student, prof.; +420602780396; vladimir.student@fnol.cz

Locations

Czechia

University hospital Olomouc; Recruiting

Olomouc, Czechia, 77900

Contact: Vladimir Student Jr., MD, PhD +420737807881 vladastudent@gmail.com

Principal Investigator: Vladimir Student Jr., MD, PhD

Sponsors and Collaborators

University Hospital Olomouc

Investigators

• Principal Investigator: Vladimir Student, MD, PhD; Dpt. of Urology

More Information

• Responsible Party: Vladimir Student, M.D., Ph.D., Vladimir Student Jr., MD, PhD, FEBU, University Hospital Olomouc
• ClinicalTrials.gov Identifier: NCT04853095
• Other Study ID Numbers: FNOl 00098892
• First Posted: April 21, 2021
• Last Update Posted: February 23, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vladimir Student, M.D., Ph.D., University Hospital Olomouc:

Prostate cancer; Robot-assisted radical prostatectomy; Extended pelvic lymph node dissection; Lymphocele; Peritoneal fixation; Lymphatic disease

Additional relevant MeSH terms:

Prostatic Neoplasms; Lymphocele; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Cysts; Lymphatic Diseases