Robotic Single Port Donor Nephrectomy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by University of Maryland
Sponsor:
Information provided by (Responsible Party):
Rolf Barth, MD, University of Maryland
ClinicalTrials.gov Identifier:
NCT01925677
First received: August 6, 2013
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

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
Single-port
Device: da Vinci® Single-Site™

Study Type: Interventional
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

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 ] [ 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: June 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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 ClinicalTrials.gov identifier: NCT01925677

Contacts
Contact: Rolf N Barth, M.D. 410 328 6020 rbarth@smail.umaryland.edu

Locations
United States, Maryland
University of Maryland Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Rolf N Barth, M.D.         
Sponsors and Collaborators
University of Maryland
Investigators
Principal Investigator: Rolf N Barth, M.D. University of Maryland
  More Information

Publications:
Responsible Party: Rolf Barth, MD, Director of Liver Transplantation, University of Maryland
ClinicalTrials.gov Identifier: NCT01925677     History of Changes
Other Study ID Numbers: HP-00055955
Study First Received: August 6, 2013
Last Updated: May 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
Transplant
donor
nephrectomy
robotic
laparoscopy
single-port

ClinicalTrials.gov processed this record on August 21, 2014