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

Robotic Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05194280
• Other study ID #: 2021_01
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: October 20, 2021

Study information

• Verified date: January 2022
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: October 20, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adult, healthy condition

Exclusion Criteria:

• Children, not suitable for kidney donation

Related Conditions & MeSH terms

• Kidney Donation
• Robotic Surgery

Intervention

Procedure:
• Robotic surgery
Robotic-assisted donornephrectomy

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC, location AMC	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain score	Visual Analogue Scale was used to measure the postoperative pain. From the operation date till discharge from the hospital	0-3 days
Secondary	Operating time	Operating time in minutes	30-300 min