Renal Autotransplantation; Case Series

Renal Tumor Clinical Trial

Official title:

Renal Autotransplantation; Case Series

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05115812
• Other study ID #: 025.HPB.2021.D
• Status: Enrolling by invitation
• Start date: September 15, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestion, Venous
• Hematuria
• Hyperemia
• Loin Pain-Hematuria Syndrome
• Renal Tumor
• Syndrome
• Vascular Diseases

Intervention

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).
• 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
• Short-Term Follow-Up Data
Adverse events, re- admissions, re-operations related to the index procedure

Locations

Country	Name	City	State
United States	Liver Institute of Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

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