Renal Autotransplantation; Case Series

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Renal Tumor; Loin Pain-Hematuria Syndrome; Renal Vascular Disease; Nutcracker Syndrome, Renal; Pelvic Trauma; Congestion, Venous
• Intervention / Treatment: Procedure: Pre-Operative Information; Procedure: Intra-Operative Data; Other: Post-Operative Data (up to discharge); Other: Short-Term Follow-Up Data

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Liver Institute of Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

RAT; patients having undergone robotic-assisted RAT procedure

Procedure: Pre-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).; Procedure: Intra-Operative Data; Operative time, total OR time, concomitant procedures, transfusions, conversions, intraoperative adverse events, autotransplantation technique; Other: Post-Operative Data (up to discharge); Postoperative adverse events, discharge status, hospital length of stay, information on enhanced recovery program; Other: Short-Term Follow-Up Data; Adverse events, re- admissions, re-operations related to the index procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline patient characteristics	Demographics-age	January 2018 until June 2021
Baseline patient characteristics- BMI	BMI, based on the American Society of Anesthesiologists status classification	January 2018 until June 2021
Baseline patient characteristics- Tobacco use	Medical History: tobacco use	January 2018 until June 2021
Baseline patient characteristics- Gender	Demographics: gender	January 2018 until June 2021
Baseline patient characteristics- Hypertension	Medical History: hypertension	January 2018 until June 2021
Baseline patient characteristics- Diabetes	Medical History: diabetes	January 2018 until June 2021
Baseline patient characteristics-cardiopulmonary disease	Medical History: cardiopulmonary disease	January 2018 until June 2021
Baseline patient characteristics-indication for RAT (Renal Autotransplantation	Medical History: indication for RAT (Renal Autotransplantation)	January 2018 until June 2021
Baseline patient characteristics-lesions	Medical History: lesions	January 2018 until June 2021
Baseline patient characteristics-previous renal revascularization	Medical History: previous renal revascularization	January 2018 until June 2021
Baseline patient characteristics-serum creatinine level	Medical History: serum creatinine level	January 2018 until June 2021
short-term clinical data-Adverse events,	Adverse events, re- admissions, re-operations related to the index procedure	up to 30 days post discharge
intraoperative characteristics-Operative time	Operative time	January 2018 until June 2021
intraoperative characteristics-total OR time	total OR time	January 2018 until June 2021
intraoperative characteristics-concomitant procedures	concomitant procedures	January 2018 until June 2021
intraoperative characteristics-transfusions	transfusions	January 2018 until June 2021
intraoperative characteristics-conversions	conversions	January 2018 until June 2021
intraoperative characteristics-intraoperative adverse events	intraoperative adverse events	January 2018 until June 2021
intraoperative characteristics-autotransplantation technique	autotransplantation technique	January 2018 until June 2021
post-operative characteristics-Post-operative adverse events	Post-operative adverse events	January 2018 until June 2021
post-operative characteristics-discharge status	discharge status	January 2018 until June 2021
post-operative characteristics-hospital length of stay	hospital length of stay	January 2018 until June 2021
post-operative characteristics-information on enhanced recovery program	information on enhanced recovery program	January 2018 until June 2021

Collaborators and Investigators

• Sponsor: Methodist Health System

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: October 8, 2021
• First Submitted That Met QC Criteria: November 9, 2021
• First Posted (Actual): November 10, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Kidney Diseases; Urologic Diseases; Disease; Hemorrhage; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Syndrome; Vascular Diseases; Hyperemia; Hematuria; Renal Nutcracker Syndrome
• Other Study ID Numbers: 025.HPB.2021.D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No