Robotic Single Port Donor Nephrectomy

Use of the Intuitive Surgical da Vinci® Single-Site™ With Instruments and Accessories for Single-Port Laparoscopic Nephrectomies

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

Study Overview

• Status: Completed
• Conditions: Robotic Surgery; Renal Transplant Donor of Left Kidney; Donor Nephrectomy; Single-port
• Intervention / Treatment: Device: da Vinci® Single-Site™

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
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Completion of the Surgical Procedure	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. The primary outcome variable is the completion of the operation for kidney donation.	during operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative Times	Operative times will closely be measured	during operation
Blood Loss	Blood loss of patients will be closely monitored and recorded.	during operation
The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies.	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. These are qualitative and were not analyzed for statistical trends.	intra-operative experience collected within 24 hours

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Rolf N Barth, M.D., University of Maryland, Baltimore

Publications and helpful links

General Publications

• Barth RN, Phelan MW, Goldschen L, Munivenkatappa RB, Jacobs SC, Bartlett ST, Philosophe B. Single-port donor nephrectomy provides improved patient satisfaction and equivalent outcomes. Ann Surg. 2013 Mar;257(3):527-33. doi: 10.1097/SLA.0b013e318262ddd6.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: August 6, 2013
• First Submitted That Met QC Criteria: August 16, 2013
• First Posted (Estimate): August 20, 2013

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: laparoscopy; Transplant; robotic; donor; nephrectomy; single-port
• Other Study ID Numbers: HP-00055955

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO