Robotic Single Port Donor Nephrectomy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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da Vinci® Single-Site™

Robotic-assisted single-incision laparoscopic nephrectomy.

Group Type EXPERIMENTAL

da Vinci® Single-Site™

Intervention Type DEVICE

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

Interventions

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da Vinci® Single-Site™

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes