Comparison of Robot-assisted Donornephrectomy vs Hand-assisted Laparoscopic Donornephrectomy

January 14, 2022 updated by: Dr. Mirza Idu, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Robot-assisted Donornephrectomy: Initial Results and Comparison With the Hand-assisted Laparoscopic Technique: A Retrospective Study

The aim of this retrospective study was to analyze donor and recipient outcomes after robotic-assisted donor nephrectomy and hand-assisted laparoscopic donornephrectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Living donor kidney transplantation is superior to cadaveric kidney transplantation because of the better patient and graft survival rates, better cost-effectiveness and improved quality of life of the recipient. According to the current guidelines, the laparoscopic technique of donor nephrectomy is now recommended as "the preferential technique". The advantages of the hand-assisted laparoscopic donor nephrectomy (HALDN) as compared with the conventional laparoscopy include tactile feedback, less kidney traction, rapid kidney removal and a shorter warm ischemic period. HALDN is nowadays the most frequently used technique in the U.S. for living donor nephrectomy. The laparoscopic techniques may have helped to increase the expansion of the donor pool. However, laparoscopic surgery have some disadvantages especially ergonomic inconveniences for the surgeon, which may result in decreased surgeons' performance and musculoskeletal disorders. Surgical robotics can play a role in extending surgical careers, by allowing surgeons to perform high volume laparoscopic surgery in a more ergonomic way. Robotic assistance in living donor nephrectomy can offer improved safety by enhanced control, accuracy, stability, and vision. The aim of this retrospective study was to compare the robotic assisted donor nephrectomy (RADN) with the HALDN technique with respect to donor and recipient outcomes.

Study Type

Observational

Enrollment (Actual)

186

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Amsterdam UMC, location AMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Kidney donors

Description

Inclusion Criteria:

  • Adult, healthy condition

Exclusion Criteria:

  • Children, not suitable for kidney donation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Robotic-assisted group
Group of patients that underwent a robotic-assisted donornephrectomy
Procedure: Robotic surgery
Robotic-assisted donornephrectomy
Hand-assisted laparoscopic group
Group of patients that underwent a hand-assisted laparoscopic donornephrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain score
Time Frame: 0-3 days
Visual Analogue Scale was used to measure the postoperative pain. From the operation date till discharge from the hospital
0-3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operating time
Time Frame: 30-300 min
Operating time in minutes
30-300 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

  • Principal Investigator: Mirza Idu, MD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

March 30, 2021

Study Completion (Actual)

October 20, 2021

Study Registration Dates

First Submitted

December 18, 2021

First Submitted That Met QC Criteria

January 14, 2022

First Posted (Actual)

January 18, 2022

Study Record Updates

Last Update Posted (Actual)

January 18, 2022

Last Update Submitted That Met QC Criteria

January 14, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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