NCT05115812

Renal Autotransplantation; Case Series

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Methodist Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-09-15
• Primary completion: 2024-09-15
• Completion: 2024-09-30
• First posted: 2021-11-10
• Last updated: 2024-03-27

Locations

1 site across 1 country: United States