Effect of Peritoneal Fixation on Lymphocele Formation (PerFix)
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|ClinicalTrials.gov Identifier: NCT04853095|
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : April 26, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Lymphocele After Surgical Procedure||Procedure: Peritoneal fixation (PerFix) Procedure: Standard of care||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||April 2022|
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
- 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
- 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.
- 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
- Change in lymphocele size [ Time Frame: 1 year ]The change in lymphocele size during follow-up CT scan will be examined
- 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
- Perioperative outcomes [ Time Frame: 30 days ]Perioperative outcomes (time of the surgery, blood loss and hospital stay) will be measured
- 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.
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04853095
|Contact: Vladimir Student Jr., MD, PhDfirstname.lastname@example.org|
|Contact: Vladimir Student, email@example.com|
|University hospital Olomouc||Recruiting|
|Olomouc, Czechia, 77900|
|Contact: Vladimir Student Jr., MD, PhD +420737807881 firstname.lastname@example.org|
|Principal Investigator: Vladimir Student Jr., MD, PhD|
|Principal Investigator:||Vladimir Student, MD, PhD||Dpt. of Urology|