Renal Autotransplantation; Case Series

NCT05115812 | Enrolling By Invitation

• 1 other identifier: 025.HPB.2021.D
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (23)

• 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

Study Arms (1)

RAT

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

Interventions

Pre-Operative Information PROCEDURE

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).

RAT

Intra-Operative Data PROCEDURE

Operative time, total OR time, concomitant procedures, transfusions, conversions, intraoperative adverse events, autotransplantation technique

RAT

Post-Operative Data (up to discharge) OTHER

Postoperative adverse events, discharge status, hospital length of stay, information on enhanced recovery program

RAT

Short-Term Follow-Up Data OTHER

Adverse events, re- admissions, re-operations related to the index procedure

RAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject was 18 years or older at the time of the procedure
• Subject who has undergone robotic RAT irrespective of the underlying etiology.

Sponsors & Collaborators

• Methodist Health System: lead

Study Sites (1)

Liver Institute of Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Renal Nutcracker Syndrome; Carcinoma, Renal Cell; Hyperemia

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2021
• First Posted: November 10, 2021
• Study Start: September 15, 2021
• Primary Completion: September 15, 2024
• Study Completion: September 30, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)