Robotic Single Port Donor Nephrectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01925677
Recruitment Status : Completed
First Posted : August 20, 2013
Last Update Posted : August 21, 2017
Information provided by (Responsible Party):
Rolf Barth, University of Maryland

Brief Summary:
Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms.

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

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.

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

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. operative times [ Time Frame: during operation ]
    Operative times will closely be measured

  2. blood loss [ Time Frame: during operation ]
    Blood loss of patients will be closely monitored and recorded.

  3. 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.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01925677

United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland
Principal Investigator: Rolf N Barth, M.D. University of Maryland

Responsible Party: Rolf Barth, Director of Liver Transplantation, University of Maryland Identifier: NCT01925677     History of Changes
Other Study ID Numbers: HP-00055955
First Posted: August 20, 2013    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Rolf Barth, University of Maryland: