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临床试验/NCT05115812
NCT05115812Enrolling By Invitation不适用

Renal Autotransplantation; Case Series

Methodist Health System1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
30
试验地点
1
主要终点
Baseline patient characteristics

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • Subjects who do not meet the inclusion criteria

结局指标

主要结局

Baseline patient characteristics

时间窗: January 2018 until June 2021

Demographics-age

Baseline patient characteristics- Hypertension

时间窗: January 2018 until June 2021

Medical History: hypertension

Baseline patient characteristics-indication for RAT (Renal Autotransplantation

时间窗: January 2018 until June 2021

Medical History: indication for RAT (Renal Autotransplantation)

Baseline patient characteristics-lesions

时间窗: January 2018 until June 2021

Medical History: lesions

Baseline patient characteristics- Tobacco use

时间窗: January 2018 until June 2021

Medical History: tobacco use

Baseline patient characteristics- Gender

时间窗: January 2018 until June 2021

Demographics: gender

Baseline patient characteristics-previous renal revascularization

时间窗: January 2018 until June 2021

Medical History: previous renal revascularization

intraoperative characteristics-Operative time

时间窗: January 2018 until June 2021

Operative time

Baseline patient characteristics- BMI

时间窗: January 2018 until June 2021

BMI, based on the American Society of Anesthesiologists status classification

Baseline patient characteristics- Diabetes

时间窗: January 2018 until June 2021

Medical History: diabetes

Baseline patient characteristics-cardiopulmonary disease

时间窗: January 2018 until June 2021

Medical History: cardiopulmonary disease

intraoperative characteristics-concomitant procedures

时间窗: January 2018 until June 2021

concomitant procedures

intraoperative characteristics-conversions

时间窗: January 2018 until June 2021

conversions

post-operative characteristics-Post-operative adverse events

时间窗: January 2018 until June 2021

Post-operative adverse events

intraoperative characteristics-autotransplantation technique

时间窗: January 2018 until June 2021

autotransplantation technique

post-operative characteristics-hospital length of stay

时间窗: January 2018 until June 2021

hospital length of stay

post-operative characteristics-information on enhanced recovery program

时间窗: January 2018 until June 2021

information on enhanced recovery program

Baseline patient characteristics-serum creatinine level

时间窗: January 2018 until June 2021

Medical History: serum creatinine level

short-term clinical data-Adverse events,

时间窗: up to 30 days post discharge

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

intraoperative characteristics-total OR time

时间窗: January 2018 until June 2021

total OR time

intraoperative characteristics-transfusions

时间窗: January 2018 until June 2021

transfusions

intraoperative characteristics-intraoperative adverse events

时间窗: January 2018 until June 2021

intraoperative adverse events

post-operative characteristics-discharge status

时间窗: January 2018 until June 2021

discharge status

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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