Effect of Peritoneal Fixation on Lymphocele Formation

NCT ID: NCT04853095

Last Updated: 2022-12-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2022-01-01

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.

Conditions

Prostate Cancer; Lymphocele After Surgical Procedure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention group (PerFix)

Peritoneal fixation technique

Group Type: EXPERIMENTAL

Peritoneal fixation (PerFix)

Intervention Type: 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.

Control group (no PerFix)

Standard of care (i.e. no fixation)

Group Type: ACTIVE_COMPARATOR

Standard of care

Intervention Type: PROCEDURE

ePLND without peritoneal flap fixation

Interventions

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.

Intervention Type: PROCEDURE

Standard of care

ePLND without peritoneal flap fixation

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Olomouc

OTHER

Sponsor Role: lead

Responsible Party

Vladimir Student, M.D., Ph.D.

Vladimir Student Jr., MD, PhD, FEBU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vladimir Student, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dpt. of Urology

Locations

University hospital Olomouc

Olomouc, , Czechia

Countries

Czechia

Other Identifiers

FNOl 00098892

Identifier Type: -

Identifier Source: org_study_id