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To assess and compare the short-term post-operative continence recovery rate in two cohorts of men undergoing Robot Assisted Radical Prostatectomy (RARP), each randomized to undergo RARP with Vattikuti Institute technique or Retzius sparing technique.
Traditionally, RARP is performed using a trans-peritoneal technique that pass anteriorly to the bladder. This technique necessitates the dissection and/or manipulation of many structures, which might compromise post-operative urinary continence recovery. These structures include the pubo-prostatic ligament, Santorini plexus, neurovascular bundle, and veil of Aphrodite. Recently, a "Retzius-sparing" technique to perform RARP has beed described. This approach passes posteriorly to the bladder, through the space of Douglas, which should minimize the damaged to the aforementioned structure. Theoretically, the latter technique should improve post-operative urinary continence recovery. However, a randomized comparison between the "traditional" RARP and "Retzius-sparing" RARP is still lacking.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | Active Comparator | Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System |
|
| Treatment arm | Experimental | Retzius sparing radical prostatectomy da Vinci Surgical System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retzius sparing radical prostatectomy | Procedure | Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| Urinary Continence Recovery | 24-hour pad weights | One week after the removal of the suprapubic urinary catheter |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Urinary Continence Recovery | 0 pad per day | within 3 months from the intervention |
| Number of Participants With Peri and Postoperative Complications | Clavien-Dindo complications |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Regained Urinary Continence Postoperatively | 0 pad per day | 1 year median follow up |
| Post-operative Urinary Function and Urinary Function-related Quality of Life | MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mani Menon, MD | Henry Ford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States | ||
| Henry Ford West Bloomfield Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28483330 | Result | Dalela D, Jeong W, Prasad MA, Sood A, Abdollah F, Diaz M, Karabon P, Sammon J, Jamil M, Baize B, Simone A, Menon M. A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy. Eur Urol. 2017 Nov;72(5):677-685. doi: 10.1016/j.eururo.2017.04.029. Epub 2017 May 6. | |
| 29225060 |
| Label | URL |
|---|---|
| A Pragmatic Randomized Controlled Trial Examining the Impact of the Retzius-sparing Approach on Early Urinary Continence Recovery After Robot-assisted Radical Prostatectomy | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm | Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique da Vinci Surgical System: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Vattikuti Urology Institute radical prostatectomy | Procedure | Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique |
|
| da Vinci Surgical System | Device | 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. |
|
| 1-year median follow up |
| Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater) | SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of >=22 is normal and >=17 is considered mild ED | 1-year median follow up |
| Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml) | Patients without biochemical evidence of disease recurrence (i.e. postop PSA >=0.2 ng/mL) | 1-year median follow up |
| Post-operative Urinary Function and Urinary Function-related Quality of Life | International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function) | Within 3 months from the intervention |
| 1 year median follow up |
| West Bloomfield |
| Michigan |
| 48322 |
| United States |
| Result |
| Menon M, Dalela D, Jamil M, Diaz M, Tallman C, Abdollah F, Sood A, Lehtola L, Miller D, Jeong W. Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard Approaches. J Urol. 2018 May;199(5):1210-1217. doi: 10.1016/j.juro.2017.11.115. Epub 2017 Dec 7. |
| Functional Recovery, Oncologic Outcomes and Postoperative Complications after Robot-Assisted Radical Prostatectomy: An Evidence-Based Analysis Comparing the Retzius Sparing and Standard Approaches | View source |
| FG001 | Treatment Arm | Retzius sparing radical prostatectomy da Vinci Surgical System Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique da Vinci Surgical System: 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Arm | Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique da Vinci Surgical System: 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. |
| BG001 | Treatment Arm | Retzius sparing radical prostatectomy da Vinci Surgical System Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique da Vinci Surgical System: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| BMI | Median | Inter-Quartile Range | kg/m^2 |
| |||||||||||||||
| preoperative prostate specific antigen level | Median | Inter-Quartile Range | ng/ml |
| |||||||||||||||
| preoperative IPSS score | International Prostatic Symptom Score (IPSS) objectively assesses urinary symptoms. It ranges from 0 to 35, with higher scores indicating worse urinary symptoms | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| preoperative SHIM score | SHIM (Sexual Health Inventory for Men) objectively asses sexual function. It ranges from 0-25, with higher scores indicating better sexual function. | Median | Inter-Quartile Range | units on a scale |
| ||||||||||||||
| NCCN clinical risk | NCCN (National Comprehensive Cancer Network) risk categorizes prostate cancer based on their likelihood of disease progression, recurrence and outcomes, into low, intermediate, high and very high risk groups. It uses clinical information (i.e information available PRIOR to surgery) for this (i.e PSA, biopsy gleason score and clinical T stage) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Urinary Continence Recovery | 24-hour pad weights | Posted | Median | Inter-Quartile Range | grams | One week after the removal of the suprapubic urinary catheter |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Urinary Continence Recovery | 0 pad per day | Posted | Number | participants | within 3 months from the intervention |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Peri and Postoperative Complications | Clavien-Dindo complications | Posted | Count of Participants | Participants | 1-year median follow up |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Regained Potency Postoperatively (as Measured by Sexual Health Inventory for Men (SHIM) Score of 17 or Greater) | SHIM ranges from 0-25 with higher scores indicating better sexual function; a score of >=22 is normal and >=17 is considered mild ED | Posted | Count of Participants | Participants | 1-year median follow up |
|
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Had Biochemical Recurrence (Post-operative Prostate-Specific Antigen (PSA) Value >=0.2 ng/ml) | Patients without biochemical evidence of disease recurrence (i.e. postop PSA >=0.2 ng/mL) | Posted | Count of Participants | Participants | 1-year median follow up |
|
| |||||||||||||||||||||||||||||||
| Secondary | Post-operative Urinary Function and Urinary Function-related Quality of Life | International Prostatic Symptom Score (continuous score from 0-35, higher scores indicating worse urinary function) | Posted | Mean | 95% Confidence Interval | score on a scale | Within 3 months from the intervention |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Patients Who Regained Urinary Continence Postoperatively | 0 pad per day | Posted | Count of Participants | Participants | 1 year median follow up |
|
| |||||||||||||||||||||||||||||||
| Other Pre-specified | Post-operative Urinary Function and Urinary Function-related Quality of Life | MSKCC (Memorial Sloan Kettering Cancer Center) STAR questionnaire (symptom tracking and reporting). Score ranges from 0-25, with higher scores indicating better urinary function | The numbers in this analyses are different from the primary analyses as some patients were lost to follow up (by one year) | Posted | Median | Inter-Quartile Range | score on a scale | 1 year median follow up |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Arm | Vattikuti Urology Institute radical prostatectomy da Vinci Surgical System Vattikuti Urology Institute radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique da Vinci Surgical System: 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. | 0 | 60 | 5 | 60 | 2 | 60 |
| EG001 | Treatment Arm | Retzius sparing radical prostatectomy da Vinci Surgical System Retzius sparing radical prostatectomy: Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique da Vinci Surgical System: 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. | 0 | 60 | 7 | 60 | 4 | 60 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphocele | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Pelvic hematoma | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Umbilical hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Acute urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Small Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Deepansh Dalela, MD | Vattikuti Urology Institute, Henry Ford Hospital | 3139162600 | ddalela1@hfhs.org |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D011469 | Prostatic Diseases |
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| Male |
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| Intermediate Risk |
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