Kidney DonationNCT05194280
Comparison of Robot-assisted Donornephrectomy vs Hand-assisted Laparoscopic Donornephrectomy
An observational study of Kidney Donation and Robotic Surgery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Kidney Donation, Robotic Surgery
- What is being tested?
- Robotic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 186 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2017to 20 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Kidney donors
Who may be able to join
- Adult, healthy condition
Who cannot join
- Children, not suitable for kidney donation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Donation, Robotic Surgery
- Being tested
- Robotic surgery
- Keywords
- Donornephrectomy, Robotic-asisted donornephrectomy, hand-assisted laparoscopic donornephrectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic surgeryProcedure or surgery
Robotic-assisted donornephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Robotic-assisted group | Group of patients that underwent a robotic-assisted donornephrectomy Receives: Procedure: Robotic surgery | |
| Hand-assisted laparoscopic group | Group of patients that underwent a hand-assisted laparoscopic donornephrectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain score
Visual Analogue Scale was used to measure the postoperative pain. From the operation date till discharge from the hospital
Measured: 0-3 days
Secondary outcomes (1)
Operating time
Operating time in minutes
Measured: 30-300 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start1 Mar 2017
- Primary completion30 Mar 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DonationStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Mirza Idu, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Mirza Idu, MD, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05194280
- Sponsor's protocol ID
- 2021_01
- Status last verified
- Jan 2022
- First submitted
- 18 Dec 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted Donornephrectomy: Initial Results and Comparison With the Hand-assisted Laparoscopic Technique: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05194280
- Acronym / sponsor ID
- 2021_01
- Conditions
- Kidney Donation, Robotic Surgery
- Keywords
- Donornephrectomy, Robotic-asisted donornephrectomy, hand-assisted laparoscopic donornephrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Mar 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this retrospective study was to analyze donor and recipient outcomes after robotic-assisted donor nephrectomy and hand-assisted laparoscopic donornephrectomy.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic-assisted group | – | Procedure: Robotic surgeryGroup of patients that underwent a robotic-assisted donornephrectomy |
| Hand-assisted laparoscopic group | – | –Group of patients that underwent a hand-assisted laparoscopic donornephrectomy. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Kidney donors
Key inclusion criteria (1 listed)
- Adult, healthy condition
Key exclusion criteria (1 listed)
- Children, not suitable for kidney donation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic surgeryRobotic-assisted donornephrectomy | Procedure or surgery | Robotic-assisted group |
Primary outcome
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
1 secondary outcome
Operating time
Time frame: 30-300 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirza Idu, MD principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Donation and Robotic Surgery, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain score (time frame: 0-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2022.