Robotic Single Port Donor Nephrectomy
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|ClinicalTrials.gov Identifier: NCT01925677|
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : August 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Transplant Donor of Left Kidney Donor Nephrectomy Robotic Surgery Single-port||Device: da Vinci® Single-Site™||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||August 2017|
|Actual Study Completion Date :||August 2017|
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.
- The amount of the operation that the robot is utilized in donor nephrectomy operations. [ Time Frame: 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.
- operative times [ Time Frame: during operation ]Operative times will closely be measured
- blood loss [ Time Frame: 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01925677
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Rolf N Barth, M.D.||University of Maryland|