An interventional study of da Vinci® Single-Site™ in Renal Transplant Donor of Left Kidney, Donor Nephrectomy and Robotic Surgery, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-20.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Supportive care
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.
University of Maryland, Baltimore is the lead sponsor of 696 studies on the registry; 131 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 63 (69%) have results posted.
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Exclusion Criteria:
Robotic-assisted single-incision laparoscopic nephrectomy.
Device: da Vinci® Single-Site™
Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
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.
Time frame: during operation
Operative Times
Operative times will closely be measured
Time frame: during operation
Blood Loss
Blood loss of patients will be closely monitored and recorded.
Time frame: 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.
Time frame: intra-operative experience collected within 24 hours
| Milestone | da Vinci® Single-Site™ |
|---|---|
| Started | 3 |
| Completed | 3 |
| Not completed | 0 |
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.
| Participants | da Vinci® Single-Site™ |
|---|---|
| Successful Completion of the Surgical Procedure | 3 |
Operative times will closely be measured
| minutes | da Vinci® Single-Site™ |
|---|---|
| Operative Times | 82 ± 16 |
Blood loss of patients will be closely monitored and recorded.
| mL | da Vinci® Single-Site™ |
|---|---|
| Blood Loss | 77 ± 64 |
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.
| participants | da Vinci® Single-Site™ |
|---|---|
| The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies. | 3 |
Collected over Data was collected for 1 year from time of surgery. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| da Vinci® Single-Site™ | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | da Vinci® Single-Site™ |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 3 |
| >=65 years | 0 |
| Age, Continuous(years) | da Vinci® Single-Site™ |
|---|---|
| Median | 52 (42 to 58) |
| Sex: Female, Male(Participants) | da Vinci® Single-Site™ |
|---|---|
| Female | 3 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | da Vinci® Single-Site™ |
|---|---|
| Race Caucasian | 3 |
| Region of Enrollment(participants) | da Vinci® Single-Site™ |
|---|---|
| United States | 3 |
| Number of participants(Participants) | da Vinci® Single-Site™ |
|---|---|
| Count of participants | 3 |
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