NCT05194280

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2022

Completed
Last Updated

January 18, 2022

Status Verified

January 1, 2022

Enrollment Period

4.1 years

First QC Date

December 18, 2021

Last Update Submit

January 14, 2022

Conditions

Kidney DonationRobotic Surgery

Keywords

DonornephrectomyRobotic-asisted donornephrectomyhand-assisted laparoscopic donornephrectomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Operating time

    30-300 min

Study Arms (2)

Robotic-assisted group

Group of patients that underwent a robotic-assisted donornephrectomy

Procedure: Robotic surgery

Hand-assisted laparoscopic group

Group of patients that underwent a hand-assisted laparoscopic donornephrectomy.

Interventions

Robotic surgeryPROCEDURE

Robotic-assisted donornephrectomy

Robotic-assisted group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Kidney donors

You may qualify if:

  • Adult, healthy condition

You may not qualify if:

  • Children, not suitable for kidney donation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, location AMC

Amsterdam, 1105 AZ, Netherlands

Location

MeSH Terms

Interventions

Robotic Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Officials

  • Mirza Idu, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 18, 2021

First Posted

January 18, 2022

Study Start

March 1, 2017

Primary Completion

March 30, 2021

Study Completion

October 20, 2021

Last Updated

January 18, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)