Robotic Single Port Donor Nephrectomy
Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms.
Renal Transplant Donor of Left Kidney
Device: da Vinci® Single-Site™
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Use of the Intuitive Surgical da Vinci® Single-Site™ With Instruments and Accessories for Single-Port Laparoscopic Nephrectomies|
- The amount of the operation that the robot is utilized in donor nephrectomy operations. [ Time Frame: during operation ] [ Designated as safety issue: Yes ]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.
- operative times [ Time Frame: during operation ] [ Designated as safety issue: No ]Operative times will closely be measured
- blood loss [ Time Frame: during operation ] [ Designated as safety issue: Yes ]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. [ Time Frame: intra-operative experience collected within 24 hours ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||July 2016 (Final data collection date for primary outcome measure)|
Experimental: da Vinci® Single-Site™
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01925677
|Contact: Rolf N Barth, M.D.||410 328 firstname.lastname@example.org|
|United States, Maryland|
|University of Maryland Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator: Rolf N Barth, M.D.|
|Principal Investigator:||Rolf N Barth, M.D.||University of Maryland|