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临床试验/NCT04435171
NCT04435171已完成不适用

Comparison of Postoperative Early Period Quality of Life of Patients With Open and Robot Assisted Kidney Transplantation: a Prospective Observational Study

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 129 人开始时间: 2016年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
129
试验地点
1
主要终点
Percentage of change for Quality of Life (measure : Short Form 36) after open and robot assisted renal transplantation

研究概览

简要总结

The investigators aimed to investigate the quality of life in patients with end-stage renal disease who underwent open or robot-assisted renal transplantation. Also, the investigators sought to determine the parameters which can affect the quality of life in these patients

详细描述

Patients who underwent open or robot-assisted renal transplantation at Bakirkoy Sadi Konuk Training and Research Hospital between June 2016 and December 2018 constituted the target population of this study. After application of the inclusion and exclusion criteria, the patient group was divided into two groups as per the surgical technique (i.e., open vs. robot-assisted). Demographic data, preoperative and postoperative data of all patients were collected prospectively. The quality of life of the patients was assessed preoperatively and on the postoperative 30th day

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged between 18 and 75
  • Who were diagnosed with End Stage Renal Disease (i.e., estimated glomerular filtration rate loer than 20 ml/minute or symptomatic uremia or dialysis requirement)
  • Received a kidney from a live donor

排除标准

  • Patients with mental retardation, dementia, and psychotic or cognitive disorders, including delirium
  • Patients who underwent deceased renal transplantation and who underwent simple bilateral nephrectomy or any other surgical procedure concurrent with Open renal transplantation
  • Patients who died or had graft failure during the study period

结局指标

主要结局

Percentage of change for Quality of Life (measure : Short Form 36) after open and robot assisted renal transplantation

时间窗: From just before the treatment and up to 30 days after the surgery was performed

Percentage of change for quality of life (measure : Short Form 36) for patients who performed open and robot assisted renal transplantation due to end stage renal disease. Scores of the Short Form-36 Health Survey vary between 0 and 100, a score of 0 corresponds to the lowest quality, while 100 indicates the highest quality.

次要结局

未报告次要终点

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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