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Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms.
Our center has performed over 200 single-port donor nephrectomies with standard laparoscopy and has reported patient benefits associated with a single port approach. The single port robotic platform offers the potential to ameliorate the significant technical and ergonomic challenges that currently limit more widespread application of single port donor surgery. After being informed of the potential risks and off-label use of the da Vinci Single-Site approach in our study, patients will undergo a robotic-assisted single-site donor nephrectomy performed by a two-surgeon team utilizing existing da Vinci instrumentation and Single-Site platforms. Renal mobilization and vascular dissection will be performed with manual laparoscopy performed for vascular division utilizing stapling devices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| da Vinci® Single-Site™ | Experimental | Robotic-assisted single-incision laparoscopic nephrectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| da Vinci® Single-Site™ | Device | Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Completion of the Surgical Procedure | The primary objective is to determine the feasibility measure of the current Single-Site platform to perform donor nephrectomy prior to vascular division and extraction. Specifically, it will be recorded which portions of the operation utilized the robotic device. The primary outcome variable is the completion of the operation for kidney donation. | during operation |
| Measure | Description | Time Frame |
|---|---|---|
| Operative Times | Operative times will closely be measured | during operation |
| Blood Loss | Blood loss of patients will be closely monitored and recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rolf N Barth, M.D. | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22968070 | Background | Barth RN, Phelan MW, Goldschen L, Munivenkatappa RB, Jacobs SC, Bartlett ST, Philosophe B. Single-port donor nephrectomy provides improved patient satisfaction and equivalent outcomes. Ann Surg. 2013 Mar;257(3):527-33. doi: 10.1097/SLA.0b013e318262ddd6. |
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| ID | Title | Description |
|---|---|---|
| FG000 | da Vinci® Single-Site™ | Robotic-assisted single-incision laparoscopic nephrectomy. da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | da Vinci® Single-Site™ | Robotic-assisted single-incision laparoscopic nephrectomy. da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Successful Completion of the Surgical Procedure | The primary objective is to determine the feasibility measure of the current Single-Site platform to perform donor nephrectomy prior to vascular division and extraction. Specifically, it will be recorded which portions of the operation utilized the robotic device. The primary outcome variable is the completion of the operation for kidney donation. | Posted | Count of Participants | Participants | during operation |
|
Data was collected for 1 year from time of surgery
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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 | da Vinci® Single-Site™ | Robotic-assisted single-incision laparoscopic nephrectomy. da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rolf Barth | University of Maryland, Baltimore | 4103286020 | 4103286020 | rnbarth@som.umaryland.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 5, 2013 | May 15, 2019 | Prot_SAP_000.pdf |
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| during operation |
| The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies. | A surgeon ergonomics questionnaire will be given to surgeons after performing both robotic assisted and standard laparoscopic single port donor nephrectomies. The results from both of these surveys will then be compared. These are qualitative and were not analyzed for statistical trends. | intra-operative experience collected within 24 hours |
| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Number of participants | Count of Participants | Participants |
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| Secondary | Operative Times | Operative times will closely be measured | Posted | Mean | Standard Deviation | minutes | during operation |
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| Secondary | Blood Loss | Blood loss of patients will be closely monitored and recorded. | Posted | Mean | Standard Deviation | mL | during operation |
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| Secondary | The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies. | A surgeon ergonomics questionnaire will be given to surgeons after performing both robotic assisted and standard laparoscopic single port donor nephrectomies. The results from both of these surveys will then be compared. These are qualitative and were not analyzed for statistical trends. | surgeon questionnaire | Posted | Number | participants | intra-operative experience collected within 24 hours |
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