Prostate CancerPerFixNCT04853095
Effect of Peritoneal Fixation on Lymphocele Formation
A study testing Peritoneal fixation (PerFix) in people with Prostate Cancer and Lymphocele After Surgical Procedure, run by University Hospital Olomouc at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Lymphocele After Surgical Procedure
- What is being tested?
- Peritoneal fixation (PerFix)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Dec 2019to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Being tested
- Peritoneal fixation (PerFix), Standard of care
- Keywords
- Prostate cancer, Robot-assisted radical prostatectomy, Extended pelvic lymph node dissection, Lymphocele, Peritoneal fixation, Lymphatic disease
- Medical subject headings
- Prostatic Neoplasms, Lymphocele, Lymphatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal fixation (PerFix)Procedure or surgery
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 careProcedure or surgery
ePLND without peritoneal flap fixation
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (PerFix) | Experimental | Peritoneal fixation technique Receives: Procedure: Peritoneal fixation (PerFix) |
| Control group (no PerFix) | Active comparator | Standard of care (i.e. no fixation) Receives: Procedure: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Symptomatic lymphocele
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
Measured: 3 months
Secondary outcomes (8)
Number of participants with Radiologic lymphocele on pelvic CT scan
The number of participants with radiologic lymphocele on Pelvic CT scan will be determined together with the size, location and number of detected lymphoceles.
Measured: 3 months
Rate of severe (Clavien grade ≥3) complications
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
Measured: 3 months
Change in lymphocele size
The change in lymphocele size during follow-up CT scan will be examined
Measured: 1 year
Number of participants with Occurrence of Any Venous Thromboembolism
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
Measured: 6 months
Perioperative outcomes
Perioperative outcomes (time of the surgery, blood loss and hospital stay) will be measured
Measured: 30 days
The effect of lymphocele on urinary incontinence
The rate of continent patients will be defined using pads needed per day. Continent equals to 0-1 pad per day.
Measured: 1 year
The effect of lymphocele on potency
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.
Measured: 1 year
The effect of lymphocele on lower urinary tract symptoms (LUTS)
Change in the International prostate symptom score (IPSS) questionnaire from the baseline will be assessed (scale 0-35, higher score means worse outcome).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start1 Dec 2019
- Primary completion31 Dec 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Olomouc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Student, M.D., Ph.D., University Hospital Olomouc
- Investigators
- Vladimir Student, MD, PhD, Principal investigator, Dpt. of Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853095
- Sponsor's protocol ID
- FNOl 00098892
- Acronym
- PerFix
- Status last verified
- Dec 2022
- First submitted
- 28 Feb 2021
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04853095
- Acronym / sponsor ID
- PerFix / FNOl 00098892
- Keywords
- Prostate cancer, Robot-assisted radical prostatectomy, Extended pelvic lymph node dissection, Lymphocele, Peritoneal fixation, Lymphatic disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University Hospital OlomoucUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (PerFix) | Experimental | Procedure: Peritoneal fixation (PerFix)Peritoneal fixation technique |
| Control group (no PerFix) | Active comparator | Procedure: Standard of careStandard of care (i.e. no fixation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Intervention group (PerFix) |
| Standard of careePLND without peritoneal flap fixation | Procedure or surgery | Control group (no PerFix) |
Primary outcome
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
8 secondary outcomes
Number of participants with Radiologic lymphocele on pelvic CT scan
Time frame: 3 months
Rate of severe (Clavien grade ≥3) complications
Time frame: 3 months
Change in lymphocele size
Time frame: 1 year
Number of participants with Occurrence of Any Venous Thromboembolism
Time frame: 6 months
Perioperative outcomes
Time frame: 30 days
The effect of lymphocele on urinary incontinence
Time frame: 1 year
The effect of lymphocele on potency
Time frame: 1 year
The effect of lymphocele on lower urinary tract symptoms (LUTS)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Student, MD, PhD principal investigator
Dpt. of Urology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritoneal fixation (PerFix) in people with Prostate Cancer and Lymphocele After Surgical Procedure, run by University Hospital Olomouc at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Symptomatic lymphocele (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.