Skip to content

Renal Autotransplantation; Case Series

Renal Autotransplantation; Case Series

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05115812
Enrollment
30
Registered
2021-11-10
Start date
2021-09-15
Completion date
2024-09-30
Last updated
2024-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestion, Venous, Loin Pain-Hematuria Syndrome, Nutcracker Syndrome, Renal, Pelvic Trauma, Renal Tumor, Renal Vascular Disease

Brief 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. 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.

Interventions

PROCEDUREPre-Operative Information

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).

PROCEDUREIntra-Operative Data

Operative time, total OR time, concomitant procedures, transfusions, conversions, intraoperative adverse events, autotransplantation technique

OTHERPost-Operative Data (up to discharge)

Postoperative adverse events, discharge status, hospital length of stay, information on enhanced recovery program

OTHERShort-Term Follow-Up Data

Adverse events, re- admissions, re-operations related to the index procedure

Sponsors

Methodist Health System
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Subject was 18 years or older at the time of the procedure * Subject who has undergone robotic RAT irrespective of the underlying etiology.

Exclusion criteria

* Subjects who do not meet the inclusion criteria

Design outcomes

Primary

MeasureTime frameDescription
Baseline patient characteristicsJanuary 2018 until June 2021Demographics-age
Baseline patient characteristics- BMIJanuary 2018 until June 2021BMI, based on the American Society of Anesthesiologists status classification
Baseline patient characteristics- Tobacco useJanuary 2018 until June 2021Medical History: tobacco use
Baseline patient characteristics- GenderJanuary 2018 until June 2021Demographics: gender
Baseline patient characteristics- HypertensionJanuary 2018 until June 2021Medical History: hypertension
Baseline patient characteristics- DiabetesJanuary 2018 until June 2021Medical History: diabetes
Baseline patient characteristics-cardiopulmonary diseaseJanuary 2018 until June 2021Medical History: cardiopulmonary disease
Baseline patient characteristics-indication for RAT (Renal AutotransplantationJanuary 2018 until June 2021Medical History: indication for RAT (Renal Autotransplantation)
Baseline patient characteristics-lesionsJanuary 2018 until June 2021Medical History: lesions
Baseline patient characteristics-previous renal revascularizationJanuary 2018 until June 2021Medical History: previous renal revascularization
Baseline patient characteristics-serum creatinine levelJanuary 2018 until June 2021Medical History: serum creatinine level
short-term clinical data-Adverse events,up to 30 days post dischargeAdverse events, re- admissions, re-operations related to the index procedure
intraoperative characteristics-Operative timeJanuary 2018 until June 2021Operative time
intraoperative characteristics-total OR timeJanuary 2018 until June 2021total OR time
intraoperative characteristics-concomitant proceduresJanuary 2018 until June 2021concomitant procedures
intraoperative characteristics-transfusionsJanuary 2018 until June 2021transfusions
intraoperative characteristics-conversionsJanuary 2018 until June 2021conversions
intraoperative characteristics-intraoperative adverse eventsJanuary 2018 until June 2021intraoperative adverse events
intraoperative characteristics-autotransplantation techniqueJanuary 2018 until June 2021autotransplantation technique
post-operative characteristics-Post-operative adverse eventsJanuary 2018 until June 2021Post-operative adverse events
post-operative characteristics-discharge statusJanuary 2018 until June 2021discharge status
post-operative characteristics-hospital length of stayJanuary 2018 until June 2021hospital length of stay
post-operative characteristics-information on enhanced recovery programJanuary 2018 until June 2021information on enhanced recovery program

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026