Renal Vascular DiseaseNCT05115812
Renal Autotransplantation; Case Series
An observational study of Renal Vascular Disease and Nutcracker Syndrome, Renal, run by Methodist Health System at 1 site in United States.
Trial summary
Renal autotransplantation (RAT) is a method of removing a kidney from its place of origin in a patient, repairing it, and transplanting it in another location of the body, generally the iliac fossa of the same patient.RAT is a relatively new technique; the first ever RAT procedure in the US was performed in 1963. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Vascular Disease, Nutcracker Syndrome, Renal, Pelvic Trauma
- What is being tested?
- Pre-Operative Information, Intra-Operative Data and Post-Operative Data (up to discharge)
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2021to 30 Sep 2024
- 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: This is a retrospective chart review case series study of all consecutive cases in which robotic RAT was performed that meet the study inclusion and exclusion criteria. The case series will be performed starting from January 2018 until June 2021 to include all cases of robotic RAT procedures.
Who may be able to join
- Subject was 18 years or older at the time of the procedure
- Subject who has undergone robotic RAT irrespective of the underlying etiology.
Who cannot join
- Subjects who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Liver Institute of Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Renal autotransplantation (RAT) is a method of removing a kidney from its place of origin in a patient, repairing it, and transplanting it in another location of the body, generally the iliac fossa of the same patient.RAT is a relatively new technique; the first ever RAT procedure in the US was performed in 1963. Advances in preservation and transplantation techniques have made RAT a modality that can be utilized in complex renal diseases. RAT is indicated for conditions such as renal vascular disease, nutcracker syndrome, pelvic venous congestion, pelvic trauma, refractory stone disease and, in some cases, loin pain hematuria syndrome and conventionally unresectable renal tumors.
Irrespective of the excellent outcomes shown by RAT, the conventional open approach requires a large midline xiphoid-to-pubis or flank incision for donor nephrectomy with a second pelvic incision for renal transplantation into the iliac fossa.The current gold standard approach to RAT is a laparoscopic nephrectomy followed by open auto-transplantation. However, this approach still requires a large pelvic incision. Robotic technology enables us to perform more complex minimally invasive surgery. Gordon et al. performed and reported the first completely intracorporeal robotic RAT to repair a ureteral injury in 2014.
Read the detailed description
This is a retrospective chart review case series study of all consecutive cases in which robotic RAT was performed that meet the study inclusion and exclusion criteria. The case series will be performed starting from January 2018 until June 2021 to include all cases of robotic RAT procedures.
Perioperative and short-term clinical data will be obtained from the EMR. All the data variables will be documented in the case report forms.
Because the data will have been de-identified and is archival in nature, there will be no active subject recruitment and no patient consenting is required.
- Conditions
- Renal Vascular Disease, Nutcracker Syndrome, Renal, Pelvic Trauma, Loin Pain-Hematuria Syndrome, Renal Tumor, Congestion, Venous
- Being tested
- Pre-Operative Information, Intra-Operative Data, Post-Operative Data (up to discharge), Short-Term Follow-Up Data
- Medical subject headings
- Renal Nutcracker Syndrome, Carcinoma, Renal Cell, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-Operative InformationProcedure or surgery
Demographics (e.g., age, gender), patient characteristics (e.g., BMI, American Society of Anesthesiologists class), and pre-operative medical history (e.g., tobacco use; comorbidities: hypertension, cardiopulmonary disease, diabetes; indication for RAT; lesions; previous renal revascularization; serum creatinine level).
Intra-Operative DataProcedure or surgery
Operative time, total OR time, concomitant procedures, transfusions, conversions, intraoperative adverse events, autotransplantation technique
Post-Operative Data (up to discharge)Other
Postoperative adverse events, discharge status, hospital length of stay, information on enhanced recovery program
Short-Term Follow-Up DataOther
Adverse events, re- admissions, re-operations related to the index procedure
| Study group | Role | What they receive |
|---|---|---|
| RAT | patients having undergone robotic-assisted RAT procedure Receives: Procedure: Pre-Operative Information; Procedure: Intra-Operative Data; Other: Post-Operative Data (up to discharge); Other: Short-Term Follow-Up Data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline patient characteristics
Demographics-age
Measured: January 2018 until June 2021
Baseline patient characteristics- BMI
BMI, based on the American Society of Anesthesiologists status classification
Measured: January 2018 until June 2021
Baseline patient characteristics- Tobacco use
Medical History: tobacco use
Measured: January 2018 until June 2021
Baseline patient characteristics- Gender
Demographics: gender
Measured: January 2018 until June 2021
Baseline patient characteristics- Hypertension
Medical History: hypertension
Measured: January 2018 until June 2021
Baseline patient characteristics- Diabetes
Medical History: diabetes
Measured: January 2018 until June 2021
Baseline patient characteristics-cardiopulmonary disease
Medical History: cardiopulmonary disease
Measured: January 2018 until June 2021
Baseline patient characteristics-indication for RAT (Renal Autotransplantation
Medical History: indication for RAT (Renal Autotransplantation)
Measured: January 2018 until June 2021
Baseline patient characteristics-lesions
Medical History: lesions
Measured: January 2018 until June 2021
Baseline patient characteristics-previous renal revascularization
Medical History: previous renal revascularization
Measured: January 2018 until June 2021
Baseline patient characteristics-serum creatinine level
Medical History: serum creatinine level
Measured: January 2018 until June 2021
short-term clinical data-Adverse events,
Adverse events, re- admissions, re-operations related to the index procedure
Measured: up to 30 days post discharge
intraoperative characteristics-Operative time
Operative time
Measured: January 2018 until June 2021
intraoperative characteristics-total OR time
total OR time
Measured: January 2018 until June 2021
intraoperative characteristics-concomitant procedures
concomitant procedures
Measured: January 2018 until June 2021
intraoperative characteristics-transfusions
transfusions
Measured: January 2018 until June 2021
intraoperative characteristics-conversions
conversions
Measured: January 2018 until June 2021
intraoperative characteristics-intraoperative adverse events
intraoperative adverse events
Measured: January 2018 until June 2021
intraoperative characteristics-autotransplantation technique
autotransplantation technique
Measured: January 2018 until June 2021
post-operative characteristics-Post-operative adverse events
Post-operative adverse events
Measured: January 2018 until June 2021
post-operative characteristics-discharge status
discharge status
Measured: January 2018 until June 2021
post-operative characteristics-hospital length of stay
hospital length of stay
Measured: January 2018 until June 2021
post-operative characteristics-information on enhanced recovery program
information on enhanced recovery program
Measured: January 2018 until June 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2021
- Study start15 Sep 2021
- Primary completion15 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Vascular DiseaseStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115812
- Sponsor's protocol ID
- 025.HPB.2021.D
- Status last verified
- Mar 2024
- First submitted
- 8 Oct 2021
- Last updated
- 27 Mar 2024
- 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 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Autotransplantation; Case Series
- ClinicalTrials.gov ID
- NCT05115812
- Acronym / sponsor ID
- 025.HPB.2021.D
- Conditions
- Renal Vascular Disease, Nutcracker Syndrome, Renal, Pelvic Trauma, Loin Pain-Hematuria Syndrome, Renal Tumor, Congestion, Venous
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 10 Nov 2021 (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.
Renal autotransplantation (RAT) is a method of removing a kidney from its place of origin in a patient, repairing it, and transplanting it in another location of the body, generally the iliac fossa of the same patient.RAT is a relatively new technique; the first ever RAT procedure in the US was performed in 1963. Advances in preservation and transplantation techniques have made RAT a modality that can be utilized in complex renal diseases. RAT is indicated for conditions such as renal vascular disease, nutcracker syndrome, pelvic venous congestion, pelvic trauma, refractory stone disease and, in some cases, loin pain hematuria syndrome and conventionally unresectable renal tumors.
Irrespective of the excellent outcomes shown by RAT, the conventional open approach requires a large midline xiphoid-to-pubis or flank incision for donor nephrectomy with a second pelvic incision for renal transplantation into the iliac fossa.The current gold standard approach to RAT is a laparoscopic nephrectomy followed by open auto-transplantation. However, this approach still requires a large pelvic incision. Robotic technology enables us to perform more complex minimally invasive surgery. Gordon et al. performed and reported the first completely intracorporeal robotic RAT to repair a ureteral injury in 2014.
Detailed description
This is a retrospective chart review case series study of all consecutive cases in which robotic RAT was performed that meet the study inclusion and exclusion criteria. The case series will be performed starting from January 2018 until June 2021 to include all cases of robotic RAT procedures.
Perioperative and short-term clinical data will be obtained from the EMR. All the data variables will be documented in the case report forms.
Because the data will have been de-identified and is archival in nature, there will be no active subject recruitment and no patient consenting is required.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAT | – | Procedure: Pre-Operative Information, Procedure: Intra-Operative Data, Other: Post-Operative Data (up to discharge), Other: Short-Term Follow-Up Datapatients having undergone robotic-assisted RAT procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective chart review case series study of all consecutive cases in which robotic RAT was performed that meet the study inclusion and exclusion criteria. The case series will be performed starting from January 2018 until June 2021 to include all cases of robotic RAT procedures.
Key inclusion criteria (2 listed)
- Subject was 18 years or older at the time of the procedure
- Subject who has undergone robotic RAT irrespective of the underlying etiology.
Key exclusion criteria (1 listed)
- Subjects who do not meet the inclusion criteria
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 |
|---|---|---|
| Pre-Operative InformationDemographics (e.g., age, gender), patient characteristics (e.g., BMI, American Society of Anesthesiologists class), and pre-operative medical history (e.g., tobacco use; comorbidities: hypertension, cardiopulmonary disease, diabetes; indication for RAT; lesions; previous renal revascularization; serum creatinine level). | Procedure or surgery | RAT |
| Intra-Operative DataOperative time, total OR time, concomitant procedures, transfusions, conversions, intraoperative adverse events, autotransplantation technique | Procedure or surgery | RAT |
| Post-Operative Data (up to discharge)Postoperative adverse events, discharge status, hospital length of stay, information on enhanced recovery program | Other | RAT |
| Short-Term Follow-Up DataAdverse events, re- admissions, re-operations related to the index procedure | Other | RAT |
Primary outcome
Baseline patient characteristics
Time frame: January 2018 until June 2021
Demographics-age
Baseline patient characteristics- BMI
Time frame: January 2018 until June 2021
BMI, based on the American Society of Anesthesiologists status classification
Baseline patient characteristics- Tobacco use
Time frame: January 2018 until June 2021
Medical History: tobacco use
Baseline patient characteristics- Gender
Time frame: January 2018 until June 2021
Demographics: gender
Baseline patient characteristics- Hypertension
Time frame: January 2018 until June 2021
Medical History: hypertension
Baseline patient characteristics- Diabetes
Time frame: January 2018 until June 2021
Medical History: diabetes
Baseline patient characteristics-cardiopulmonary disease
Time frame: January 2018 until June 2021
Medical History: cardiopulmonary disease
Baseline patient characteristics-indication for RAT (Renal Autotransplantation
Time frame: January 2018 until June 2021
Medical History: indication for RAT (Renal Autotransplantation)
Baseline patient characteristics-lesions
Time frame: January 2018 until June 2021
Medical History: lesions
Baseline patient characteristics-previous renal revascularization
Time frame: January 2018 until June 2021
Medical History: previous renal revascularization
Baseline patient characteristics-serum creatinine level
Time frame: January 2018 until June 2021
Medical History: serum creatinine level
short-term clinical data-Adverse events,
Time frame: up to 30 days post discharge
Adverse events, re- admissions, re-operations related to the index procedure
intraoperative characteristics-Operative time
Time frame: January 2018 until June 2021
Operative time
intraoperative characteristics-total OR time
Time frame: January 2018 until June 2021
total OR time
intraoperative characteristics-concomitant procedures
Time frame: January 2018 until June 2021
concomitant procedures
intraoperative characteristics-transfusions
Time frame: January 2018 until June 2021
transfusions
intraoperative characteristics-conversions
Time frame: January 2018 until June 2021
conversions
intraoperative characteristics-intraoperative adverse events
Time frame: January 2018 until June 2021
intraoperative adverse events
intraoperative characteristics-autotransplantation technique
Time frame: January 2018 until June 2021
autotransplantation technique
post-operative characteristics-Post-operative adverse events
Time frame: January 2018 until June 2021
Post-operative adverse events
post-operative characteristics-discharge status
Time frame: January 2018 until June 2021
discharge status
post-operative characteristics-hospital length of stay
Time frame: January 2018 until June 2021
hospital length of stay
post-operative characteristics-information on enhanced recovery program
Time frame: January 2018 until June 2021
information on enhanced recovery program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Vascular Disease and Nutcracker Syndrome, Renal, 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 27 Mar 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?
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?
Baseline patient characteristics (time frame: January 2018 until June 2021). The study lists 23 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 27 Mar 2024.