Robotic Single Port Donor Nephrectomy

Study Overview
=================
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.

Official Title
-----------------
Use of the Intuitive Surgical da Vinci® Single-Site™ With Instruments and Accessories for Single-Port Laparoscopic Nephrectomies

Conditions
-----------------
Renal Transplant Donor of Left Kidney, Donor Nephrectomy, Robotic Surgery, Single-port

Intervention / Treatment
-----------------
* Device: da Vinci® Single-Site™


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: da Vinci® Single-Site™<br>Robotic-assisted single-incision laparoscopic nephrectomy. | Device: da Vinci® Single-Site™<br>* Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nephrectomy, Transplant, donor, robotic, laparoscopy, single-port