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OpenTrials
Completed

NCT Number: NCT01925677

Robotic Single Port Donor Nephrectomy

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

da Vinci® Single-Site™

Device

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

Primary outcomes

  1. Successful Completion of the Surgical Procedure

    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. The primary outcome variable is the completion of the operation for kidney donation.

Secondary outcomes

  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. These are qualitative and were not analyzed for statistical trends.

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 20, 2013
Registry last updated
Nov 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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