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Robotic Single Port Donor Nephrectomy

University of Maryland Baltimore (UMB) logo

University of Maryland Baltimore (UMB)

Status

Completed

Conditions

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

Treatments

Device: da Vinci® Single-Site™

Study type

Interventional

Funder types

Other

Identifiers

NCT01925677
HP-00055955

Details and patient eligibility

About

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

Full 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.

Enrollment

3 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

3 participants in 1 patient group

da Vinci® Single-Site™
Experimental group
Description:
Robotic-assisted single-incision laparoscopic nephrectomy.
Treatment:
Device: da Vinci® Single-Site™

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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