Robotic Single Port Donor Nephrectomy

• Sponsor: University of Maryland, Baltimore (Other)
• Overall Status: Completed
• CT.gov ID: NCT01925677
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arm: 1
• Duration (Months): 31
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Renal Transplant Donor of Left Kidney; Donor Nephrectomy; Robotic Surgery; Single-port	Device: da Vinci® Single-Site™	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Use of the Intuitive Surgical da Vinci® Single-Site™ With Instruments and Accessories for Single-Port Laparoscopic Nephrectomies
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Aug 1, 2017
• Actual Study Completion Date: Aug 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: da Vinci® Single-Site™ Robotic-assisted single-incision laparoscopic nephrectomy.	Device: da Vinci® Single-Site™; Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.

Outcome Measures

Primary Outcome Measures

1. 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

1. Operative Times [during operation]

   Operative times will closely be measured

2. Blood Loss [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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Maryland Medical Center	Baltimore	Maryland	United States	21201

Sponsors and Collaborators

• University of Maryland, Baltimore

Investigators

• Principal Investigator: Rolf N Barth, M.D., University of Maryland, Baltimore

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 5, 2013

More Information

Publications

• 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.

• Responsible Party: Rolf Barth, Director of Liver Transplantation, University of Maryland, Baltimore
• ClinicalTrials.gov Identifier: NCT01925677
• Other Study ID Numbers: HP-00055955
• First Posted: Aug 20, 2013
• Last Update Posted: Nov 20, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Rolf Barth, Director of Liver Transplantation, University of Maryland, Baltimore: Transplant; donor; nephrectomy; robotic; laparoscopy; single-port

Study Results

Participant Flow

Arm/Group Title	da Vinci® Single-Site™
Arm/Group Description	Robotic-assisted single-incision laparoscopic nephrectomy. da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
Period Title: Overall Study
STARTED	3
COMPLETED	3
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	da Vinci® Single-Site™
Arm/Group Description	Robotic-assisted single-incision laparoscopic nephrectomy. da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
Overall Participants	3
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 100%
>=65 years	0 0%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	52
Sex: Female, Male (Count of Participants)
Female	3 100%
Male	0 0%
Race/Ethnicity, Customized (Count of Participants)
Race Caucasian	3 100%
Region of Enrollment (participants) [Number]
United States	3 100%
Number of participants (Count of Participants)
Count of Participants [Participants]	3 100%

Outcome Measures

1. Primary Outcome

Title	Successful Completion of the Surgical Procedure
Description	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.
Time Frame	during operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	da Vinci® Single-Site™
Arm/Group Description	Robotic-assisted single-incision laparoscopic nephrectomy. da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
Measure Participants	3
Count of Participants [Participants]	3 100%

2. Secondary Outcome

Title	Operative Times
Description	Operative times will closely be measured
Time Frame	during operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	da Vinci® Single-Site™
Arm/Group Description	Robotic-assisted single-incision laparoscopic nephrectomy. da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
Measure Participants	3
Mean (Standard Deviation) [minutes]	82 (16)

3. Secondary Outcome

Title	Blood Loss
Description	Blood loss of patients will be closely monitored and recorded.
Time Frame	during operation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	da Vinci® Single-Site™
Arm/Group Description	Robotic-assisted single-incision laparoscopic nephrectomy. da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
Measure Participants	3
Mean (Standard Deviation) [mL]	77 (64)

4. Secondary Outcome

Title	The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies.
Description	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.
Time Frame	intra-operative experience collected within 24 hours

Outcome Measure Data

Analysis Population Description

surgeon questionnaire

Arm/Group Title	da Vinci® Single-Site™
Arm/Group Description	Robotic-assisted single-incision laparoscopic nephrectomy. da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
Measure Participants	3
Number [participants]	3 100%

Adverse Events

Time Frame	Data was collected for 1 year from time of surgery
Arm/Group Title	da Vinci® Single-Site™
Arm/Group Description	Robotic-assisted single-incision laparoscopic nephrectomy. da Vinci® Single-Site™: Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
All Cause Mortality
	da Vinci® Single-Site™
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Serious Adverse Events
	da Vinci® Single-Site™
	Affected / at Risk (%)	# Events
Total	0/3 (0%)
Other (Not Including Serious) Adverse Events
	da Vinci® Single-Site™
	Affected / at Risk (%)	# Events
Total	0/3 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.