TransplantNCT04182607
Donor Outcomes Following Hand-Assisted and Robotic Living Donor Nephrectomy: a Retrospective Review
An observational study of Transplant and Kidney Diseases, run by Methodist Health System at 1 site in United States.
Trial summary
1.1. Background: Renal transplantation is the treatment of choice for eligible patients with end-stage renal disease. It provides better outcomes in terms of life expectancy and quality of life than dialysis (Liu, Narins, Maley, Frank, \& Lallas, 2012). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant, Kidney Diseases
- What is being tested?
- kidney transplant
- Type of treatment
- Surgery or procedure
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to Nov 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Data from all patients who had a hand-assisted or robotic minimally invasive kidney transplantation procedure at Methodist Dallas Medical Center (MDMC) between January 2006 and November 2019 will be included in the study
Who may be able to join
- ≥ 18 years of age
- Kidney donors and recipients who underwent a hand-assisted or robotic kidney transplant
Who cannot join
- Patients that do not meet the Study Inclusion Criteria laid out above
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, 75203
Elaina Vivian, MPH, 214.933.6611, ElainaVivian@mhd.com
Colette Ngo Ndjom, MS, 214-947-4681, ColetteNgoNdjom@mhd.com
About this study
1.1. Background: Renal transplantation is the treatment of choice for eligible patients with end-stage renal disease. It provides better outcomes in terms of life expectancy and quality of life than dialysis (Liu, Narins, Maley, Frank, \& Lallas, 2012). Kidney transplants from living donors also have additional benefits in terms of graft function and survival compared to transplants from cadaver donors (Galvani et al., 2012). Living donor transplants provide an opportunity to have good quality grafts and to perform the procedure when the recipient is in an optimal clinical status (Creta et al., 2019).
Laparoscopic donor nephrectomy was first introduced in 1995 and is currently accepted as the gold standard for kidney procurement from living donors. The first worldwide robotic assisted laparoscopic donor nephrectomy was performed in 2000 by Horgan et al. (Horgan et al., 2007).
Read more
The main obstacle to living donation is the exposure of a healthy subject to the risks of a major surgical intervention. Therefore, efforts have been made to reduce complications and postoperative pain, achieve faster recovery, and minimize the surgical incisions.
Minimally invasive procedures like hand-assisted and robotic approaches greatly enhance living donation rates, and in 2001 the number of living donors exceeded the number of cadaver donors (Horgan et al., 2007).
1.2. Aim(s)/Objective(s): The objective of this study is to compare intra- and postoperative patient outcomes of kidney donors following hand-assisted and robotic kidney transplants at a single center.
1.3. Rationale for the study: More research is needed regarding the differences between minimally invasive approaches to kidney transplantation.
Read the detailed description
This is a retrospective, single-center cohort study. Clinical data will be collected from electronic medical records (EMRs) on donors and recipients who underwent a minimally invasive kidney transplantation procedure. Data from all patients who had a hand-assisted or robotic minimally invasive kidney transplantation procedure at Methodist Dallas Medical Center (MDMC) between January 2006 and November 2019 will be included in the study.
- Conditions
- Transplant, Kidney Diseases
- Being tested
- kidney transplant
- Keywords
- kidney, transplant, nephrectomy
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kidney transplantProcedure or surgery
Also called nephrectomy
Clinical data will be collected from electronic medical records (EMRs) on donors and recipients who underwent a minimally invasive kidney transplantation procedure
| Study group | Role | What they receive |
|---|---|---|
| hand-assisted kidney transplant | Kidney donors and recipients who underwent a hand-assisted kidney transplant Receives: Procedure: kidney transplant | |
| robotic kidney transplant | Kidney donors and recipients who underwent a robotic kidney transplant Receives: Procedure: kidney transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient demographics
Patient demographics of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Measured: between January 2006 and November 2019
Kidney Laterality
A chart review of which kidney (left versus right) was donated
Measured: between January 2006 and November 2019
operating room (OR) time (minutes)
operating room (OR) time (minutes) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Measured: between January 2006 and November 2019
warm ischemia time (minutes)
warm ischemia time (minutes) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Measured: between January 2006 and November 2019
estimated blood loss (EBL) (milliliters (mL))
estimated blood loss (EBL) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Measured: between January 2006 and November 2019
complications (using Clavien-Dindo scale)
complications (using Clavien-Dindo scale) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Measured: between January 2006 and November 2019
hospital length of stay (LOS) (days from admit to discharge)
hospital length of stay (LOS) (days from admit to discharge) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Measured: between January 2006 and November 2019
30-day readmissions
30-day readmissions of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Measured: between January 2006 and November 2019
BMI (kilogram per square meter (kg/m^2))
BMI (kilogram per square meter (kg/m^2)) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Measured: between January 2006 and November 2019
hospital-based charges/costs
hospital-based charges/costs of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Measured: between January 2006 and November 2019
creatinine levels at discharge (milligrams per deciliter (mg/dL))
creatinine levels at discharge (milligrams per deciliter (mg/dL)) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Measured: between January 2006 and November 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start6 Nov 2019
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TransplantStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Mejia, MD, Principal investigator, The Liver Institute at Methodist Dallas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182607
- Sponsor's protocol ID
- 063.HPB.2019.D
- Status last verified
- Sep 2024
- First submitted
- 27 Nov 2019
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data will be accessed by the principal investigator and delegated staff only for the duration of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor Outcomes Following Hand-Assisted and Robotic Living Donor Nephrectomy: a Retrospective Review
- ClinicalTrials.gov ID
- NCT04182607
- Acronym / sponsor ID
- 063.HPB.2019.D
- Conditions
- Transplant, Kidney Diseases
- Keywords
- kidney, transplant, nephrectomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 2 Dec 2019 (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.
1.1. Background: Renal transplantation is the treatment of choice for eligible patients with end-stage renal disease. It provides better outcomes in terms of life expectancy and quality of life than dialysis (Liu, Narins, Maley, Frank, \& Lallas, 2012). Kidney transplants from living donors also have additional benefits in terms of graft function and survival compared to transplants from cadaver donors (Galvani et al., 2012). Living donor transplants provide an opportunity to have good quality grafts and to perform the procedure when the recipient is in an optimal clinical status (Creta et al., 2019).
Laparoscopic donor nephrectomy was first introduced in 1995 and is currently accepted as the gold standard for kidney procurement from living donors. The first worldwide robotic assisted laparoscopic donor nephrectomy was performed in 2000 by Horgan et al. (Horgan et al., 2007).
The main obstacle to living donation is the exposure of a healthy subject to the risks of a major surgical intervention. Therefore, efforts have been made to reduce complications and postoperative pain, achieve faster recovery, and minimize the surgical incisions.
Minimally invasive procedures like hand-assisted and robotic approaches greatly enhance living donation rates, and in 2001 the number of living donors exceeded the number of cadaver donors (Horgan et al., 2007).
1.2. Aim(s)/Objective(s): The objective of this study is to compare intra- and postoperative patient outcomes of kidney donors following hand-assisted and robotic kidney transplants at a single center.
1.3. Rationale for the study: More research is needed regarding the differences between minimally invasive approaches to kidney transplantation.
Detailed description
This is a retrospective, single-center cohort study. Clinical data will be collected from electronic medical records (EMRs) on donors and recipients who underwent a minimally invasive kidney transplantation procedure. Data from all patients who had a hand-assisted or robotic minimally invasive kidney transplantation procedure at Methodist Dallas Medical Center (MDMC) between January 2006 and November 2019 will be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hand-assisted kidney transplant | – | Procedure: kidney transplantKidney donors and recipients who underwent a hand-assisted kidney transplant |
| robotic kidney transplant | – | Procedure: kidney transplantKidney donors and recipients who underwent a robotic kidney transplant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data from all patients who had a hand-assisted or robotic minimally invasive kidney transplantation procedure at Methodist Dallas Medical Center (MDMC) between January 2006 and November 2019 will be included in the study
Key inclusion criteria (2 listed)
- ≥ 18 years of age
- Kidney donors and recipients who underwent a hand-assisted or robotic kidney transplant
Key exclusion criteria (1 listed)
- Patients that do not meet the Study Inclusion Criteria laid out above
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 |
|---|---|---|
| kidney transplantAlso: nephrectomyClinical data will be collected from electronic medical records (EMRs) on donors and recipients who underwent a minimally invasive kidney transplantation procedure | Procedure or surgery | hand-assisted kidney transplant, robotic kidney transplant |
Primary outcome
Patient demographics
Time frame: between January 2006 and November 2019
Patient demographics of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Kidney Laterality
Time frame: between January 2006 and November 2019
A chart review of which kidney (left versus right) was donated
operating room (OR) time (minutes)
Time frame: between January 2006 and November 2019
operating room (OR) time (minutes) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
warm ischemia time (minutes)
Time frame: between January 2006 and November 2019
warm ischemia time (minutes) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
estimated blood loss (EBL) (milliliters (mL))
Time frame: between January 2006 and November 2019
estimated blood loss (EBL) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
complications (using Clavien-Dindo scale)
Time frame: between January 2006 and November 2019
complications (using Clavien-Dindo scale) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
hospital length of stay (LOS) (days from admit to discharge)
Time frame: between January 2006 and November 2019
hospital length of stay (LOS) (days from admit to discharge) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
30-day readmissions
Time frame: between January 2006 and November 2019
30-day readmissions of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
BMI (kilogram per square meter (kg/m^2))
Time frame: between January 2006 and November 2019
BMI (kilogram per square meter (kg/m^2)) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
hospital-based charges/costs
Time frame: between January 2006 and November 2019
hospital-based charges/costs of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
creatinine levels at discharge (milligrams per deciliter (mg/dL))
Time frame: between January 2006 and November 2019
creatinine levels at discharge (milligrams per deciliter (mg/dL)) of donors and recipients will be compared between surgical techniques (i.e., hand-assisted vs. robotic).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No. Individual Participant Data will be accessed by the principal investigator and delegated staff only for the duration of the trial.
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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.
Alejandro Mejia, MD principal investigator
The Liver Institute at Methodist Dallas Medical Center
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 Transplant and Kidney Diseases, run by Methodist Health System at 1 site in United States.
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 2 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: status not confirmed, as of the sponsor's last update on 20 Nov 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Crystee Cooper, DHEd (214-947-1280, clinicalresearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient demographics (time frame: between January 2006 and November 2019). The study lists 11 primary outcomes in all. 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 20 Nov 2024.