Clinical trial NCT05115812: Renal Autotransplantation; Case Series
Official title: Renal Autotransplantation; Case Series
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Renal Vascular Disease
Nutcracker Syndrome, Renal
Pelvic Trauma
Loin Pain-Hematuria Syndrome
Renal Tumor
Congestion, Venous
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2021-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Baseline patient characteristics
timeFrame: January 2018 until June 2021
measure: Baseline patient characteristics- BMI
timeFrame: January 2018 until June 2021
measure: Baseline patient characteristics- Tobacco use
timeFrame: January 2018 until June 2021
measure: Baseline patient characteristics- Gender
timeFrame: January 2018 until June 2021
measure: Baseline patient characteristics- Hypertension
timeFrame: January 2018 until June 2021
measure: Baseline patient characteristics- Diabetes
timeFrame: January 2018 until June 2021
measure: Baseline patient characteristics-cardiopulmonary disease
timeFrame: January 2018 until June 2021
measure: Baseline patient characteristics-indication for RAT (Renal Autotransplantation
timeFrame: January 2018 until June 2021
measure: Baseline patient characteristics-lesions
timeFrame: January 2018 until June 2021
measure: Baseline patient characteristics-previous renal revascularization
timeFrame: January 2018 until June 2021
measure: Baseline patient characteristics-serum creatinine level
timeFrame: January 2018 until June 2021
measure: short-term clinical data-Adverse events,
timeFrame: up to 30 days post discharge
measure: intraoperative characteristics-Operative time
timeFrame: January 2018 until June 2021
measure: intraoperative characteristics-total OR time
timeFrame: January 2018 until June 2021
measure: intraoperative characteristics-concomitant procedures
timeFrame: January 2018 until June 2021
measure: intraoperative characteristics-transfusions
timeFrame: January 2018 until June 2021
measure: intraoperative characteristics-conversions
timeFrame: January 2018 until June 2021
measure: intraoperative characteristics-intraoperative adverse events
timeFrame: January 2018 until June 2021
measure: intraoperative characteristics-autotransplantation technique
timeFrame: January 2018 until June 2021
measure: post-operative characteristics-Post-operative adverse events
timeFrame: January 2018 until June 2021
measure: post-operative characteristics-discharge status
timeFrame: January 2018 until June 2021
measure: post-operative characteristics-hospital length of stay
timeFrame: January 2018 until June 2021
measure: post-operative characteristics-information on enhanced recovery program
timeFrame: January 2018 until June 2021
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Liver Institute of Methodist Dallas Medical Center
state: Texas
Study officials:
References: