Robotic Single Port Donor Nephrectomy

N/ACompletedNCT01925677

University of Maryland, Baltimore3 enrolled

Overview

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

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

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Renal Transplant Donor of Left Kidney Donor Nephrectomy Robotic Surgery Single-port

Interventions

da Vinci® Single-Site™DEVICE

Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Maryland Medical Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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.

Time frame: during operation

Secondary Outcomes

Operative Times

Operative times will closely be measured

Time frame: during operation

Blood Loss

Blood loss of patients will be closely monitored and recorded.

Time frame: 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.

Time frame: intra-operative experience collected within 24 hours

Data from ClinicalTrials.gov

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