Trial Outcomes & Findings for Robotic Single Port Donor Nephrectomy (NCT NCT01925677)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 participants

Primary outcome timeframe

during operation

Results posted on

2019-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	da Vinci® Single-Site™ 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 Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Robotic Single Port Donor Nephrectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	da Vinci® Single-Site™ n=3 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Race Caucasian	3 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants
Number of participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	da Vinci® Single-Site™ n=3 Participants 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.
Successful Completion of the Surgical Procedure	3 Participants

SECONDARY outcome

Timeframe: during operation

Operative times will closely be measured

Outcome measures

Outcome measures
Measure	da Vinci® Single-Site™ n=3 Participants 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.
Operative Times	82 minutes Standard Deviation 16

SECONDARY outcome

Timeframe: during operation

Blood loss of patients will be closely monitored and recorded.

Outcome measures

Outcome measures
Measure	da Vinci® Single-Site™ n=3 Participants 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.
Blood Loss	77 mL Standard Deviation 64

SECONDARY outcome

Timeframe: intra-operative experience collected within 24 hours

Population: surgeon questionnaire

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.

Outcome measures

Outcome measures
Measure	da Vinci® Single-Site™ n=3 Participants 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.
The Comparison of Surgeon Ergonomic Questionnaires in Robotic Assisted Versus Standard Laparoscopic Single Port Donor Nephrectomies.	3 participants

Adverse Events

da Vinci® Single-Site™

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Rolf Barth

University of Maryland, Baltimore

Phone: 4103286020

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place