Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Blood and Lymph Conditions

Symptoms and General Pathology

Prostatic Neoplasms

Lymphocele

Lymphatic Diseases

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Cysts

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.

Peritoneal fixation (PerFix)

Standard of care

Vladimir Student, MD, PhD

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.

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.

Effect of Peritoneal Fixation on Lymphocele Formation

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 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

The number of participants with radiologic lymphocele on Pelvic CT scan will be determined together with the size, location and number of detected lymphoceles.

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

The change in lymphocele size during follow-up CT scan will be examined

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 of the surgery, blood loss and hospital stay) will be measured

The rate of continent patients will be defined using pads needed per day. Continent equals to 0-1 pad per day.

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.

Change in the International prostate symptom score (IPSS) questionnaire from the baseline will be assessed (scale 0-35, higher score means worse outcome).

University Hospital Olomouc

Vladimir Student Jr., MD, PhD, FEBU

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Coagulants

All Drugs and Chemicals

Thrombin

Thrombin gel matrix applicated after conventional pelvic lymphadenectomy

Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy

Thrombi-Gel

Conventional Pelvic lymphadenectomy

Şener Gezer, M.D

To compare the incidence of lymphocele in Endometrial cancer patients with thrombin gel matrix used and not used during pelvic lymph node dissection.

Pelvic lymph node dissection is the most accurate staging tool to determine lymph node involvement in endometrial cancer. Lymphoceles developed after surgery can cause serious morbidity, additional costs and delays in chemotherapy or radiotherapy. In this study, conventional pelvic lymphadenectomy will be compared with thrombin gel matrix application after pelvic lymphadenectomy. Our goal is to prospectively assess the lymphostatic effect of thrombin gel matrix in endometrial cancer patients undergoing pelvic lymph node dissection.

Application of Thrombin gel matrix after Pelvic lymphadenectomy. And compare this application with Conventional Pelvic Lymphadenectomy.

Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.

Frequency pelvic lymphocele at post-operative 2th month

Volume of lymphocele detected with radiographic imagining at post-operative 2th month (the two largest dimensions measured in centimetres)

duration of postoperative drainage catheter

Postoperative drain amount (ml: milliliters)

Kocaeli University

Principal Investigator

Postoperative Complications

In the intervention group, a ventral fixation was performed by suturing the ventral bladder peritoneum to the plexus Santorini and from there to the right and left lateral endopelvic fascia (MICHL-stitch).

Michl-stitch

Uwe Michl

A two-armed prospective randomised, controlled, single-centre trial on 1080 patients with prostate cancer who underwent robot-assisted radical prostatectomy with bilateral pelvic lymph node dissection was carried out. Patients in the intervention arm received fixation of the peritoneal flap of the bladder to the plexus Santorini at the end of surgery (Michl-technique, MT); in the control group, surgery was performed without this modification. The primary endpoint was the rate of lymphoceles requiring intervention.

MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles

Prospective Randomised Study to Examine the Influence of a Modification of the DaVinci Prostatectomy on the Frequency of Postoperative Lymphoceles Requiring Treatment and Postoperative Complications

A publication in a peer-reviewed journal is planned

Martini-Klinik am UKE GmbH

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Thrombosis

Pulmonary Embolism

Embolism

Thromboembolism

Venous Thromboembolism

Venous Thrombosis

Embolism and Thrombosis

Vascular Diseases

Lung Diseases

Respiratory Tract Diseases

Fibrinolytic Agents

Anticoagulants

Heparin

Calcium heparin

Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge.

Patients randomized to the control arm will receive routine care with intermittent pneumatic compression devices.

5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.

Subcutaneous Heparin

Mohamad E Allaf, MD

The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy (RP).

The PREVENTER Trial aims to compare the use of perioperative pharmacologic prophylaxis (subcutaneous heparin) with intermittent pneumatic compression devices (IPCs) to the use of IPCs alone for the prevention of venous thromboembolism (VTE) after radical prostatectomy (RP). Currently, there is no standard practice for VTE prophylaxis after RP with the American Urological Association recommending "pharmacological or pneumatic mechanical prophylaxis" for high risk patients. Prior studies showed 30% of patients in the United States received no perioperative prophylaxis and less than 20% received pharmacologic agents, compared to 98% of patients receiving pharmacologic prophylaxis in the United Kingdom. Some urologists prescribe patients low molecular weight heparin (LMWH) after discharge for up to 30 days after surgery. Additionally, there are no established risks of pharmacologic prophylaxis for RP patients, but some urologists express concern about the potential impact of prophylaxis on the rate of postoperative lymphoceles or hematomas. At Johns Hopkins, patients do not routinely receive pharmacologic VTE prophylaxis in the perioperative setting for RP. Given the lack of standard practice and implications for patient safety, the investigators propose a prospective, stratified randomized controlled trial to evaluate the impact of perioperative pharmacologic prophylaxis on VTE following RP hypothesizing that it will prevent VTE events without significantly impacting the rate of postoperative bleeding or lymphoceles. The potential impact of surveillance bias with differential imaging between arms, effect of lymphadenectomy (yes/no and number of noted removed) or surgical approach (robotic and open), and differences by patients risk (comorbidity and VTE risk based on components of the Caprini score) or demographics will be assessed.

Prospective, single-institution, multi-surgeon, stratified randomized controlled trial. Randomization will be stratified into four groups by procedure approach (open or robotic) and whether patients elect to undergo a screening 30-day lower extremity Duplex (ultrasound or no ultrasound). Patients will then be randomized, within each of the strata, to the two arms (subcutaneous heparin versus no subcutaneous heparin).

PREvention of VENous ThromboEmbolism Following Radical Prostatectomy

A Randomized Controlled Trial for PREvention of VENous ThromboEmbolism Following Radical Prostatectomy (PREVENTER Trial)

Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE). The primary outcome is diagnosis of DVT or PE within 30 days after surgery due to imaging (any method, most commonly lower extremity ultrasound or computed tomography scan with pulmonary embolus protocol) prompted by symptoms of a DVT (lower extremity swelling, pain, fever of unknown origin) or PE (chest pain, shortness of breath, hypoxemia, tachycardia or fever of unknown origin, productive cough with bloody sputum).

This outcome is defined as a surgical or pelvic fluid collection diagnosed as a hematoma (blood collection, with or without infection) or lymphocele (collection of lymph fluid in the pelvis) due to symptoms (fever, abdominal pain, nausea or vomiting, anemia, high surgical drain output) within 30 days after surgery.

This additional primary outcome includes the development and diagnosis of any major clinically recognized bleeding event within 30 days after surgery requiring \>1 unit of packed red blood cell transfusion, intervention to stop bleeding, or return to the operating room.

DVT or PE diagnosed for any reason within 30 days after surgery. This includes any diagnosed DVT or PE as described in the primary outcome plus any additional DVTs or PEs diagnosed at 30 day screening lower extremity ultrasound for patients opting to undergo screening bilateral lower extremity Duplex ultrasound at 30 days who do not have symptoms.

The total recorded intraoperative estimated blood loss in milliliters reported at the end of the surgery.

The total output in milliliters from any surgical drain left in place (not all patients will necessarily have a surgical drain) after surgery and until discharge from the hospital (usually 1 to 2 days). Drain output, if one is left in place after discharge, will not count toward this secondary outcome.

Patients in each arm receiving postoperative diagnostic imaging for venous thromboembolism relative to symptoms (e.g. lower extremity Duplex ultrasound, spiral CT angiography, V/Q scan).

Johns Hopkins University

Patients randomized to the pharmacologic VTE prophylaxis arm will receive a dose of subcutaneous heparin 5,000 units prior to incision, and subcutaneous heparin 5,000 units every 8 hours after surgery until discharge.

Subcutaneous Heparin: 5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.

Control

Total

Age, Continuous

Sex: Female, Male

White

African American

Hispanic

Asian

Race/Ethnicity, Customized

The study met a futility end point at the 2nd interim analysis (pre-planned in the study protocol) leading to an appropriate decision for early closure and termination rather than continuing to planned enrollment of N=666.

Dr. Mohamad Allaf

One participant in the control arm was lost to follow-up precluding outcome assessment.

Number of Participants With Symptomatic Venous Thromboembolism

Number of Participants With Symptomatic Postoperative Fluid Collection

Number of Participants With Major Postoperative Bleeding

Only the subset receiving ultrasound are analyzed for this outcome.

Number of Participants With Occurrence of Any Venous Thromboembolism

Estimated Blood Loss During Surgery

Surgical Drain Output After Surgery

Surveillance Bias by Differential Use of Imaging as Assessed by Number of Participants Receiving Postoperative Diagnostic Imaging for Venous Thromboembolism Relative to Symptoms

Overall Study

standard lymphadenectomy using clips and bipolar cautery to seal lymphatic vessels

lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels

After pelvic lymph node dissection, lymphatic vessels will be sealed by formation of a peritoneal iliac flap in which the bladder in folded over the area of lymph node dissection

After pelvic lymph node dissection, lymphatic vessels will be sealed using the standard approach

Standard surgical approach

Lymphoceles are a potentially serious complication of radical prostatectomy (RP) with pelvic lymph node dissection. They are associated with abdominal pain, urinary tract symptoms, fever, lower extremity swelling and deep vein thrombosis. They can be severe enough to necessitate intervention in 5% of patients after RRP with PLND, with sequela that could include infection and nerve damage. Studies evaluating strategies to preclude lymphocele formation after RP have included comparisons of the use of titanium clips vs bipolar coagulation to seal lymphatic vessels during pelvic lymph node dissection. In a recent prospective randomized trial comparing these approaches, no differences were observed in the rates of lymphocele formation as detected by ultrasound. There is a need to continue to test potential strategies to minimize the formation of lymphoceles after RRP.

Creation of a peritoneal iliac flap is one approach has potential towards this end. At the Lahey Hospital and Medical Center in Burlington, MA surgeons routinely fold the bladder into a peritoneal flap to overlay the area of extended lymphadenectomy. It is thought that this method prevents the formation of lymphoceles because the flap creates a window, which allows drainage of the lymph fluid into the peritoneal cavity to be reabsorbed. While the Lahey study supports the safety and effectiveness of the peritoneal flap approach, the procedure has never been evaluated through a randomized prospective trial and the practice is certainly not standard of care. We therefore propose a randomized, prospective clinical trial to be conducted in the Hartford Hospital Urology Department to examine the effectiveness of a peritoneal iliac flap on the formation of lymphoceles after RRP with pelvic lymph node dissection.

Hypotheses:

1. We hypothesize that, at 3 months after RP, rates of lymphocele formation (symptomatic and asymptomatic lymphoceles) will be significantly lower in patients who have pelvic lymph node dissection using the peritoneal iliac flap approach than in patients who have pelvic lymph node dissection using the standard approach.
2. Lymphoceles are often associated with lower urinary tract symptoms. We hypothesize that, after RP, severity of urinary bother symptoms and urinary incontinence will be significantly lower at each measurement period for patients who had pelvic lymph node dissection using the peritoneal iliac flap approach relative to patients who had pelvic lymph node dissection using the standard approach.

Neither the patient nor the surgeon (who is also the investigator) will know to which arm patients are randomized (standard surgical approach) or experimental approach

Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy

The Effect of a Peritoneal Iliac Flap on Lymphocele Formation After Robotic Radical Prostatectomy

Formation of a least one lymphocele as detected by pelvic ultrasound 3 months after surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Peritoneal Fixation on Lymphocele Formation	NCT04853095	Prostate Cancer Lymphocele Afte...	Peritoneal fixa... Standard of car...	18 Years -	University Hospital Olomouc
Application of Thrombin Gel Matrix for the Prevention of Lymphocele in Patients With Endometrial Cancer.	NCT04205864	Lymphocele Lymphocele Afte... Endometrium Can...	Thrombi-Gel Conventional Pe...	18 Years - 90 Years	Kocaeli University
Effect of Peritoneal Fixation on Lymphocele Formation	NCT04853095	Prostate Cancer Lymphocele Afte...	Peritoneal fixa... Standard of car...	18 Years -	University Hospital Olomouc
MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles	NCT06284135	Lymphocele Afte...	Michl-stitch	18 Years -	Martini-Klinik am UKE GmbH
PREvention of VENous ThromboEmbolism Following Radical Prostatectomy	NCT03006562	Prostate Cancer Venous Thromboe... Lymphocele Afte... Deep Venous Thr... Pulmonary Embol...	Subcutaneous He...	18 Years - 100 Years	Johns Hopkins University
Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy	NCT03567525	Lymphocele Afte...	lymph node diss... Standard surgic...	18 Years - 80 Years	Hartford Hospital
Peritoneal Iliac Flap and Lymphocele Formation After Robotic Radical Prostatectomy	NCT03567525	Lymphocele Afte...	lymph node diss... Standard surgic...	18 Years - 80 Years	Hartford Hospital
MICHL-trial: Impact of Peritoneal Bladder Flap in RARP Patients on Lymphoceles	NCT06284135	Lymphocele Afte...	Michl-stitch	18 Years -	Martini-Klinik am UKE GmbH

Spots Global Cancer Trial Database for lymphocele after surgical procedure