Clinical trial NCT01925677: Robotic Single Port Donor Nephrectomy
Official title: Use of the Intuitive Surgical da Vinci® Single-Site™ With Instruments and Accessories for Single-Port Laparoscopic Nephrectomies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Transplant Donor of Left Kidney
Donor Nephrectomy
Robotic Surgery
Single-port
Keywords: Transplant
donor
nephrectomy
robotic
laparoscopy
single-port
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2013-08-20
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Successful Completion of the Surgical Procedure
timeFrame: during operation
Secondary outcomes:
measure: Operative Times
timeFrame: during operation
measure: Blood Loss
timeFrame: during operation
measure: The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies.
timeFrame: intra-operative experience collected within 24 hours
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Rolf N Barth, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.