Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Symmcora® Long-term bidirectional barbed suture for vesicourethral anastomosis in patients undergoing robotic assisted radical prostatectomy.

Adult male patients undergoing elective robotic assisted radical prostatectomy.will be included in the study

robotic assisted radical prostatectomy

Irene Fita Esteban

Anna Ibañez Jimenez

Miguel Sánchez Encinas, Dr.

Carlos Hernandez Rios, Dr.

Dr. Miguel Sánchez Encinas, Dr.

The aim of this observational study is to show the superiority of the bidirectional barbed suture (Symmcora® Longterm) in terms of time to perform the vesicourethral anastomosis after robot assisted radical prostatectomy compared to the available literature data, without an increase in the complication rate.

Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy

Prospective, Multicenter, Single-arm Study on the Performance of Symmcora® Long-term Bidirectional Barbed Suture for Vesicourethral Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy.

Handling of the suture is assessed for every participating surgeon once after inclusion of the last patient. Handling is measured in 16 dimensions + overall impression with five evaluation levels (excellent, very good, good, satisfied, poor)

Handling of the suture is assessed for every participating surgeon once after inclusion of the last patient. Handling is measured in 13 dimensions + overall impression with five evaluation levels (excellent, very good, good, satisfied, poor)

Time to perform the vesicourethral anastomosis using a stopwatch. Time starts when the needle passes the first time the tissue and ends after completion of the anastomosis. Completion of the anastomosis is defined by the last cut of the thread.

Blood loss is estimated by the amount of intraoperatively needed transfusion

Amount of transfused blood, Calculated by multiplication of the number of bags needed and the volume in ml per bag

Urinary retention is an inability to completely empty the bladder

A urogenital fistula is an abnormal tract that exists between the urinary tract and bladder, ureters, or urethra. A urogenital fistula can occur between any of the organs and structures of the pelvic region. A fistula allows urine to continually exit through and out the urogenital tract.

Cumulative rate of patients with a complication related to the bladder neck contracture

Cumulative rate of patients with a complication related to urinary stone formation

Cumulative rate of patients with any other complication (infection, embolization, peritonitis, ileus, etc.)

Time to perform the intervention from first cut to last cut of the last thread. The time is measured using a stopwatch.

Time to perform the modified Rocco stitch: After prostate extirpation, the free edge of the Denonvillier fascia is approximated to the posterior rhabdosphincter/median raphe using a running suture. Then, the Denonvilliers' fascia is fixated to the posterior wall of the bladder, which reduces tension in the anastomosis and provides pelvic support to the bladder neck. The time is measured using a stopwatch.

Number of days from surgery till patient is discharged from hospital

Number of days from surgery till catheter was finally removed

Days after catheter was finally removed to complete continence

The 24-hour pad test is used as an objective diagnostic method for the assessment of post prostatectomy stress urinary incontinence. Pads are weighed before and after use and the amount of urine is measured.

Erectile Function measured by International Index of Erectile Function (IIEF-5). The International Index of Erectile Function-5 (IIEF-5) is an five-item Index developed to diagnose the presence and severity of erectile dysfunction (ED). The five items are based on ability to identify the presence or absence of ED and on adherence to the National Institute of Health's definition of ED. These items focus on erectile function and intercourse satisfaction. The items are rated on a scale from 1-5 (e.g., 1=Very low to 5=Very high; 1=Almost never/never to 5=Almost always/always; 1=Extremely difficult to 5=Not difficult). The IIEF-5 score is the sum of questions 1 to 5 (Scores range from 5-25). ED was classified into five severity levels, ranging from none (22-25) through severe (5-7).

The International prostate symptom score (IPSS) questionnaire has seven questions, which are used to evaluate storage and voiding symptoms. The patient is given ﬁve options for the ﬁrst seven questions and each option indicates severity of that symptom. The total score ranges from 0 to 35 and Lower Urinary Tract Symptoms (LUTS) are classiﬁed as mild to severe depending on the total score. Patients having a total score ≤7 are classiﬁed as having mild symptoms, scores from 8 to 19 are classiﬁed as moderate symptoms, and symptom scores ≥20 are classiﬁed as severe symptoms.

PSA response will be measured as the change of serum PSA in ng/mL between preoperative / screening examination and at follow-up 6 weeks after surgery

B.Braun Surgical SA

Aesculap AG

Behaviors and Mental Disorders

Symptoms and General Pathology

Erectile Dysfunction

Hypothermia

Urinary Incontinence

Enuresis

Urination Disorders

Urologic Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Lower Urinary Tract Symptoms

Urological Manifestations

Mental Disorders

Psychotic Disorders

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Body Temperature Changes

After Subjects arrive at the MRI facility, subjects will fill out a medical questionnaire that will be used to determine whether a MRI study can be performed. The investigators will determine whether there are any problems that make the subject not suitable for participating in this study.

Thomas E Ahlering, MD

Urinary incontinence and sexual dysfunction are potential side effects for men undergoing the successful removal of the cancerous prostate via surgery. Hypothermic cooling via the investigational Endorectal Cooling Balloon has been shown by our group to significantly reduce long term urinary incontinence and may reduce sexual dysfunction in men after robotic prostatectomy, and improve the patient's long term quality of life (QOL). However before successful translation of the endorectal balloon can proceed into the world wide usage, we must understand:

1. How effectively the tissues for continence and sexual function are cooled within the pelvis.
2. What is the capacity of vascularized structures (i.e. the neurovascular bundle) to 'cool sink' or diminish the effective cooling and
3. Determine if the endorectal balloon can be re-designed for improved QOL outcomes in men.

This research study marries two new techniques of Thermal MRI imaging and Endorectal cooling for prostate cancer surgery. MRI is non-invasive. A simple confirmation of effective hypothermic cooling can be achieved by novel MRI thermal mapping of the cooling gradient as it comprehensively sweeps through the rectum across the urogenital pelvis. MRI with temperature adaptive software can accurately map these gradients with non-invasive technique, and answer formidable questions of the effectiveness of hypothermic cooling of the prostate and its direct translation into improved continence and sexual function after surgery. The purpose of this research study is to use Magnetic Resonance Imaging (MRI) and Thermal MRI with subjects who will receive the investigational endorectal cooling balloon to help further understand how the cooling balloon works, which may translate to other uses in the future, including the diagnosis of patients at a high risk of developing prostate cancer.

Prostate cancer is the second most frequent cause of cancer death in men and it accounts for 11% of all male cancers. Radical prostatectomy remains the gold standard for localized disease, offering the advantage of precise staging and grading and the real possibility of disease eradication. In the US there are approximately 100,000 radical prostatectomies (RP) performed for prostate cancer annually. However, there are two major challenges to the quality of life outcomes after radical prostatectomy: preserving urinary continence, and sexual function. The quality of life (QOL) after radical prostatectomy relies on the return of continence and sexual function after surgery to their pre-operative 'normal' status. The main factor which determines potency rates for patients is whether or not the nerves at the Neurovascular Bundles (NVB), are spared, and it may take years for sexual function to return. This may be due to the nerve injury from the nerve trauma in the surgical procedure. Similarly, a major factor involved in post-radical prostatectomy incontinence is preservation of the nerves that control the external urethral sphincter, bladder, and urogenital diaphragm. Also Inflammation from surgical removal of the prostate not only affects nerves, but also may directly damage the bladder, urethra, and pelvic floor. Effective strategies to prevent this damage are currently lacking. One stratagem to prevent or minimize such damage, is the use of local hypothermia with ice or cold irrigation around the nerves and tissues prior to, during, and after the injury has occurred. In numerous experimental models of central and peripheral nervous system injury, the use of moderate hypothermia (i.e. 28-33oC) has been shown to provide dramatic neuroprotection safely in humans, during cardiac, kidney, and brain surgery for many years.

MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

MRI (Magnetic Resonance Imaging) Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon

During pre and post hypothermia, initial temperatures will be measured simultaneously on five 3-mm-thick image slices that covered the target. The thermometry scan can be repeated every 6 s. Tissue temperature map is measured by magnetic resonance thermometry (echo planar imaging with multiphase; field of view: 25 × 25 cm; matrix 256 × 256; number of excitations: 1; repetition time: 545 ms; echo time: 20 ms; flip angle: 20°; slice thickness: 3 mm); (b) a thermal map of the tissue volume will be superimposed on the anatomical image.

Before the subject's scheduled radical prostatectomy surgery, they will have an MRI combined with an cooling endorectal balloon (this study), which will 1. Show the dimensions of their lower pelvis, including the prostate, and 2.Measure how cold the tissue around the prostate becomes using the cooling balloon. The thermal MRI images will allow elucidation of temperatures at specified anatomic locations and their changes over time. Data will be described using means for normally distributed continuous variables. We will test for associations between temperature and continence using t-tests to compare temperature change between those who achieve continence at 30 and 60 days and those who do not.

University of California, Irvine

Vice Chairman and Urology Professor

Nutritional and Metabolic Diseases

Dehydration

Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.

Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.

Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.

Amniotic Membrane Placement

Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.

EPIC 26

Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.

PSA Measurement

SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.

Sexual History Inventory for Men

Sanoj Punnen, MD

The use of dehydrated human amnionic membrane allograft improves erectile function recovery (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic assisted radical prostatectomy (RARP) compared to a control group with no allograft.

This is a phase 2 prospective randomized trial investigating the impact of amniotic membrane placement over the neurovascular bundles after bilateral nerve sparing robot assisted radical prostatectomy on potency. The study will have a control arm that will follow standard of care surgery, without placement of any membranes. 70 men will be allocated to each arm.

The research study will involve follow up every 3 months for the first 12 months. After this the investigators will follow patients annually with prostate-specific antigen (PSA) measurements and an assessment of any secondary therapies for 5 years post-surgery.

Randomization of study patients will be done in equal proportion to Arm I (membrane placement) and Arm II (no membrane placement, standard of care surgery) using a permuted block design stratified by baseline SHIM score (\<17 vs. \>=17), and use of ANY erectile aids (Yes vs. No) in the last 3 months.

Participants will not know their treatment arm assignment until after robotic assisted radical prostatectomy (RARP) surgery.

Miami Membrane for Potency (MMEP) Trial

Miami Membrane for Potency (MMeP) Trial to Assess the Impact of Dehydrated Human Amnion Membrane Allograft Placement During Robotic Radical Prostatectomy on Early Return of Erectile Function

The difference in average change in Sexual History Inventory for Men (SHIM) score, between baseline and 12 months post RARP between the membrane and control arms will be assessed as the primary endpoint. The SHIM score is measured in points on a scale: The minimum score is 5 to 7 indicating severe erectile dysfunction (ED), the maximum score is 22 to 25, indicating no ED.

Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group with mild ED or better, defined by a SHIM greater than or equal to 17, at 3, 6, 9 and 12 months post RARP.

Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group who are able to achieve an erection sufficient for intercourse more than 50% of the time at 3, 6, 9 and 12 months post RARP.

Among men with a SHIM greater than or equal to 17 at baseline, the investigators will evaluate the proportion of men who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis) at 3, 6, 9, and 12 months post RARP.

Rates of urinary control as measured by no pads per day at 3, 6, 9, and 12 months,

Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy.

Vivex Biomedical

University of Miami

Associate Professor of Clinical

Per protocol, non-serious adverse events (AEs) were only monitored, assessed and recorded if they were attributed to the membrane placement during the RARP procedure.

Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.

Amniotic Membrane Placement: Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.

EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.

PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.

SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.

Arm 1 - Amniotic Membrane Placement

Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals.

EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.

PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.

SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.

Arm 2 - No Amniotic Membrane Placement

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Sexual History Inventory for Men (SHIM) psychosocial questionnaire. The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows:

* 22 - 25: No significant erectile dysfunction
* 17 - 21: Mild erectile dysfunction
* 12 - 16: Mild-to-moderate erectile dysfunction
* 8 - 11: Moderate erectile dysfunction
* 5 - 7: Severe erectile dysfunction

SHIM Score

A measure of the amount of prostate-specific antigen (PSA) in the blood.

PSA Level

Due to early study termination, not all study participants completed scheduled visits.

Sanoj Punnen MD, MAS

The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group

Mild or Better ED, Baseline

Mild or Better ED, 3 months

Mild or Better ED, 6 months

Mild or Better ED, 9 months

Mild or Better ED, 12 months

Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits.

Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP

3 months

6 months

9 months

12 months

Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.

3 months Post-RARP

6 months Post-RARP

9 months Post-RARP

12 months Post-RARP

Arm 1: Amniotic Membrane Placement

Arm 2: No Amniotic Membrane Placement

Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP

No Pad Usage: Baseline

No Pad Usage: 3 months post-RARP

No Pad Usage: 6 months Post-RARP

No Pad Usage: 9 months Post-RARP

No Pad Usage: 12 months Post-RARP

Rates of Urinary Control Experienced by Study Participants

Data were not collected due to early termination of study.

5-year Rate of Prostate Cancer Recurrence Between Both Study Arms

Overall Study

Digestive System Diseases

Pneumoperitoneum

This group receives 12mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy.

This group receives 15mm Hg of pneumoperitoneum pressure during robotic assisted radical prostatectomy (RARP). This pressure is the standard amount used for all RARP procedures.

Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 12 mmHg (experimental) or 15mm Hg (standard technique).

Pressure applied during RARP

Kevin Keating, DO

Thomas Maatman, DO

Cindy Karl, BSN

Joan Westendorp, BSN

The purpose of this study is to evaluate clinical significance of low pressure pneumoperitoneum during robotically assisted radical prostatectomy (RARP).

Laparoscopic and robotic surgery has revolutionized post-operative outcomes across surgical specialties. However, the use of pneumoperitoneum comes with known risks given the change in physiological parameters that accompany its utilization. The effects of increased intra-abdominal pressure on cardiopulmonary function has been well documented. Increased pressure on the large vessels may lead to decreased cardiac output and thereby decreased blood flow to various organ systems and cause irreversible damage. Some studies have advocated lower pressures to further optimize cardiopulmonary parameters. McDougall, et. al, for instance, demonstrated a significant reduction in oliguria when pressures of 10mm Hg were used. The purpose of this study is to evaluate the effect of using lower pressure pneumoperitoneum in the abdominal cavity during RARP. The investigators hypothesize that low pressure pneumoperitoneum has a multitude of clinical benefits due to improved physiologic parameters including a reduction in the occurrence of post-operative ileus, reduced need for narcotics post operatively, and a decrease in cardiopulmonary complications. A previously completed study concluded a reduction in post-operative ileus at a pneumoperitoneum pressure of 8 mm Hg vs 12 mm Hg. This new study will evaluate the standard pneumoperitoneum pressure of 15 mm Hg vs 12 mm Hg in order to validate the previous study vs the standard pneumoperitoneum pressure.

The study is a prospective randomized blinded cohort study. Patients who meet eligibility criteria will be randomly assigned to undergo RARP at a pneumoperitoneum pressure of 15mm Hg or 12mm Hg. This will be done by computer generated randomization protocol. Surgeon and patients will be blinded to the pneumoperitoneum pressure used. A cover will be placed over the insufflation system so that the surgeon(s) are not able to visualize the pneumoperitoneum used during the procedure. The remainder of the procedure will be carried out based on current standard of care. All patients will be admitted post operatively and the same standardized orderset in EPIC EHR will be used for all patients in order to control for other factors, such as opioid use, to control for confounders.

The Impact of Low Pressure Pneumo in RARP II

The Impact of Low Pressure Pneumoperitoneum in Robotic Assisted Radical Prostatectomy: A Prospective Randomized Controlled Trial II

Reduction in the occurrence of Post-Operative Ileus after RARP

Reduction in the need for narcotics post operatively

Reduced blood loss during robot assisted radical prostatectomy

Reduction in post operative complications as measured by Clavien-Dindo Complication Score

Metro Health, Michigan

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Respiratory Tract Infections

Lymphocele

Cysts

Lymphatic Diseases

Coagulants

All Drugs and Chemicals

Hemostatics

Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.

Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.

J-Plasma

Vipul R Patel, MD

This study protocol will evaluate the efficacy of Bovie Medical's J-Plasma® helium based plasma technology in the reduction of lymphoceles following pelvic lymph node dissection (PLND) during robotic assisted radical prostatectomy (RARP). The J-Plasma® handpiece will be used during the PLND by dissecting the lymph nodes and sealing the lymphatic channels to prevent lymph leakage.

Participants evaluated and scheduled for a PLND during Robotic Assisted Radical Prostatectomy who have met the study inclusion criteria and who have also given informed consent will be enrolled. Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels. An abdominal-pelvic ultrasound will be completed at a follow-up period ranging from 4-12 weeks post operatively to determine if a lymphocele is present. The occurrence rate of lymphoceles in this trial group will be compared to retrospective data from the principal investigator's practice and other published data to determine if the occurrence rate has been reduced.

Cold Plasma for the Reduction of Lymphoceles Following PLND

Application of Cold Plasma Energy for Reduction of Lymphoceles Following Pelvic Lymph Node Dissection During Robot-Assisted Radical Prostatectomy

The primary outcome to be measured will be the incidence of lymphocele formation as diagnosed upon post- operative abdominal ultrasound.

AdventHealth

Apyx Medical

Enrolled participants will have their PLND performed using J-Plasma® for dissection and sealing of lymphatic channels.

J-Plasma: Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.

Pre-Op Prostate-Specific Antigen (PSA)

Gleason scores range from 2 to 10, and most prostate cancer will score 6 or higher. A higher score (8 to 10) means the type of cancer has a higher risk of growing and spreading.

Pre-Operative Biopsy Gleason

Kari Larson

Number of Participants With Incidence of Lymphocele Formation

Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System

Retzius sparing radical prostatectomy da Vinci Surgical System

Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique

Retzius sparing radical prostatectomy

Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique

Vattikuti Urology Institute radical prostatectomy

The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy	NCT06055946	Prostate Cancer	robotic assiste...	18 Years -	Aesculap AG
MRI Temperature Mapping of the Prostate and Urogenital Pelvis Cooled by an Endorectal Balloon	NCT01979848	Prostate Cancer Hypothermia Urinary Inconti... Erectile Dysfun...		21 Years -	University of California, Irvine
Miami Membrane for Potency (MMEP) Trial	NCT02710422	Prostate Cancer	Amniotic Membra... EPIC 26 PSA Measurement Sexual History ...	40 Years - 80 Years	University of Miami
The Impact of Low Pressure Pneumo in RARP II	NCT04394676	Prostate Cancer	Pressure applie...	40 Years -	Metro Health, Michigan
Cold Plasma for the Reduction of Lymphoceles Following PLND	NCT02658851	Lymphoceles Fol...	J-Plasma	18 Years - 80 Years	Apyx Medical
Impact of Robot-assisted Radical Prostatectomy Technique on Short-term Continence Recovery	NCT02352103	Urinary Inconti...	Retzius sparing... Vattikuti Urolo... da Vinci Surgic...	40 Years - 75 Years	Henry Ford Health System
Symmcora® Long-term Bidirectional Barbed Suture for Anastomosis in Patients Undergoing Robot Assisted Radical Prostatectomy	NCT06055946	Prostate Cancer	robotic assiste...	18 Years -	Aesculap AG
Miami Membrane for Potency (MMEP) Trial	NCT02710422	Prostate Cancer	Amniotic Membra... EPIC 26 PSA Measurement Sexual History ...	40 Years - 80 Years	University of Miami

Spots Global Cancer Trial Database for robotic assisted radical prostatectomy