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Effect of Peritoneal Fixation on Lymphocele Formation

NCT04853095 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2022-12-16

No results posted yet for this study

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.

Conditions

Interventions

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.

PROCEDURE

Standard of care

ePLND without peritoneal flap fixation

Sponsors & Collaborators

  • University Hospital Olomouc

    lead OTHER

Principal Investigators

  • Vladimir Student, MD, PhD · Dpt. of Urology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2021-12-31
Completion
2022-01-01

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04853095 on ClinicalTrials.gov