Robotic Single Port Donor Nephrectomy

NCT01925677 | Completed Results

• 1 other identifier: HP-00055955
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Transplant; donor; nephrectomy; robotic; laparoscopy; single-port

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Operative Times

  during operation

• Blood Loss

  during operation

• The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies.

  intra-operative experience collected within 24 hours

Study Arms (1)

da Vinci® Single-Site™

EXPERIMENTAL

Robotic-assisted single-incision laparoscopic nephrectomy.

Device: da Vinci® Single-Site™

Interventions

da Vinci® Single-Site™ DEVICE

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

da Vinci® Single-Site™

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related 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.

  PMID: 22968070 BACKGROUND

Results Point of Contact

• Title: Dr. Rolf Barth
• Organization: University of Maryland, Baltimore

rnbarth@som.umaryland.edu

4103286020

Study Officials

• Rolf N Barth, M.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Liver Transplantation

Study Record Dates

• First Submitted: August 6, 2013
• First Posted: August 20, 2013
• Study Start: January 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)