An observational study in Renal Vascular Disease, Nutcracker Syndrome, Renal and Pelvic Trauma, sponsored by Methodist Health System. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-27.
Sponsored by Methodist Health System · Observational
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.
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.
2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.
This study's planned enrollment of 30 is below the median of 151 across 337 observational studies indexed under Carcinoma, Renal Cell.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
patients having undergone robotic-assisted RAT procedure
Procedure: Pre-Operative Information · Procedure: Intra-Operative Data · Other: Post-Operative Data (up to discharge) · Other: Short-Term Follow-Up Data
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).
Operative time, total OR time, concomitant procedures, transfusions, conversions, intraoperative adverse events, autotransplantation technique
Postoperative adverse events, discharge status, hospital length of stay, information on enhanced recovery program
Adverse events, re- admissions, re-operations related to the index procedure
Baseline patient characteristics
Demographics-age
Time frame: January 2018 until June 2021
Baseline patient characteristics- BMI
BMI, based on the American Society of Anesthesiologists status classification
Time frame: January 2018 until June 2021
Baseline patient characteristics- Tobacco use
Medical History: tobacco use
Time frame: January 2018 until June 2021
Baseline patient characteristics- Gender
Demographics: gender
Time frame: January 2018 until June 2021
Baseline patient characteristics- Hypertension
Medical History: hypertension
Time frame: January 2018 until June 2021
Baseline patient characteristics- Diabetes
Medical History: diabetes
Time frame: January 2018 until June 2021
Baseline patient characteristics-cardiopulmonary disease
Medical History: cardiopulmonary disease
Time frame: January 2018 until June 2021
Baseline patient characteristics-indication for RAT (Renal Autotransplantation
Medical History: indication for RAT (Renal Autotransplantation)
Time frame: January 2018 until June 2021
Baseline patient characteristics-lesions
Medical History: lesions
Time frame: January 2018 until June 2021
Baseline patient characteristics-previous renal revascularization
Medical History: previous renal revascularization
Time frame: January 2018 until June 2021
Baseline patient characteristics-serum creatinine level
Medical History: serum creatinine level
Time frame: January 2018 until June 2021
short-term clinical data-Adverse events,
Adverse events, re- admissions, re-operations related to the index procedure
Time frame: up to 30 days post discharge
intraoperative characteristics-Operative time
Operative time
Time frame: January 2018 until June 2021
intraoperative characteristics-total OR time
total OR time
Time frame: January 2018 until June 2021
intraoperative characteristics-concomitant procedures
concomitant procedures
Time frame: January 2018 until June 2021
intraoperative characteristics-transfusions
transfusions
Time frame: January 2018 until June 2021
intraoperative characteristics-conversions
conversions
Time frame: January 2018 until June 2021
intraoperative characteristics-intraoperative adverse events
intraoperative adverse events
Time frame: January 2018 until June 2021
intraoperative characteristics-autotransplantation technique
autotransplantation technique
Time frame: January 2018 until June 2021
post-operative characteristics-Post-operative adverse events
Post-operative adverse events
Time frame: January 2018 until June 2021
post-operative characteristics-discharge status
discharge status
Time frame: January 2018 until June 2021
post-operative characteristics-hospital length of stay
hospital length of stay
Time frame: January 2018 until June 2021
post-operative characteristics-information on enhanced recovery program
information on enhanced recovery program
Time frame: January 2018 until June 2021
Plan to share: No
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