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Robotic Single Port Donor Nephrectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Maryland
Information provided by (Responsible Party):
Rolf Barth, University of Maryland Identifier:
First received: August 6, 2013
Last updated: May 9, 2016
Last verified: May 2016
Feasibility study on robotic-assisted single-site donor nephrectomy utilizing da Vinci instrumentation and Single-Site platforms.

Condition Intervention
Renal Transplant Donor of Left Kidney
Donor Nephrectomy
Robotic Surgery
Device: da Vinci® Single-Site™

Study Type: Interventional
Study Design: 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

Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 20
Study Start Date: January 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01925677

Contact: Rolf N Barth, M.D. 410 328 6020

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

Responsible Party: Rolf Barth, Director of Liver Transplantation, University of Maryland Identifier: NCT01925677     History of Changes
Other Study ID Numbers: HP-00055955
Study First Received: August 6, 2013
Last Updated: May 9, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by University of Maryland:
single-port processed this record on March 24, 2017