Donor Nephrectomy, Renal Transplant Donor of Left Kidney, Robotic Surgery, Single-port
Conditions
Keywords
Transplant, donor, nephrectomy, robotic, laparoscopy, single-port
Brief summary
Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms.
Detailed description
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.
Interventions
DEVICEda Vinci® Single-Site™
Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient must be approved by the Living Donor Center. * Patient must have compatible blood type with the recipient. * Patient must have body mass index less than 35. * Patient must have appropriate anatomy for left kidney donation.
Exclusion criteria
* Any patient receiving anticoagulant drugs such as Coumadin or warfin * Any patient suffering from an active urinary tract infections * Any patients suffering from cancer. * Any patients suffering from diabetes. * Any patients suffering from kidney disease. * Any patients suffering from heart disease. * Any patients suffering from liver disease. * Any patients suffering from HIV or hepatitis * Any patients suffering from previous major abdominal surgery. * Any patients suffering from more than two left renal arteries.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Completion of the Surgical Procedure | during operation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Operative Times | during operation | Operative times will closely be measured |
| Blood Loss | during operation | Blood loss of patients will be closely monitored and recorded. |
| The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies. | intra-operative experience collected within 24 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | da Vinci® Single-Site™ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 52 years |
| Number of participants | 3 Participants |
| Race/Ethnicity, Customized Race Caucasian | 3 Participants |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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.
Time frame: during operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| da Vinci® Single-Site™ | Successful Completion of the Surgical Procedure | 3 Participants |
Secondary
Blood Loss
Blood loss of patients will be closely monitored and recorded.
Time frame: during operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| da Vinci® Single-Site™ | Blood Loss | 77 mL | Standard Deviation 64 |
Secondary
Operative Times
Operative times will closely be measured
Time frame: during operation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| da Vinci® Single-Site™ | Operative Times | 82 minutes | Standard Deviation 16 |
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.
Time frame: intra-operative experience collected within 24 hours
Population: surgeon questionnaire
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| da Vinci® Single-Site™ | The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies. | 3 participants |