Robotic Single Port Donor Nephrectomy

Not Applicable

Completed

• Conditions: Renal Transplant Donor of Left Kidney; Robotic Surgery; Single-port; Donor Nephrectomy
• Interventions: Device: da Vinci® Single-Site™

• Registration Number: NCT01925677
• Lead Sponsor: University of Maryland, Baltimore

Brief Summary

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

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 Timeline

• Study First Submitted: 2013-08-06
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-20
• Study Start: 2015-01
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2019-05-15
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-01
• Last Update Submitted: 2019-11-01
• Results First Posted: 2019-11-20
• Last Update Posted: 2019-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
da Vinci® Single-Site™	da Vinci® Single-Site™	Robotic-assisted single-incision laparoscopic nephrectomy.

Primary Outcome Measures

Name	Time	Method
Successful Completion of the Surgical Procedure	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 Outcome Measures

Name	Time	Method
Blood Loss	during operation	Blood loss of patients will be closely monitored and recorded.
Operative Times	during operation	Operative times will closely be measured
The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies.	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.

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States