Robotic Single Port Donor Nephrectomy

Robotic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01925677
• Other study ID #: HP-00055955
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: August 2017

Study information

• Verified date: November 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• da Vinci® Single-Site™
Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative Times	Operative times will closely be measured	during operation
Secondary	Blood Loss	Blood loss of patients will be closely monitored and recorded.	during operation
Secondary	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