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临床试验/NCT03717259
NCT03717259已完成不适用

Recovery of Short-term Renal Function in Post-transplant Patients Living Donor: Comparison Between Graft Procurement Techniques - Open Surgery, Laparoscopic Assisted Hand and Pure Laparoscopic

Instituto Mexicano del Seguro Social0 个研究点目标入组 508 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
508
主要终点
Rate of medical complications in renal graft recipients through 30 day after the nephrectomy.

研究概览

简要总结

Objectives: To describe and analyze the perioperative and functional evolution of short-term renal graft in patients with kidney transplantation from a live donor, comparing three surgical techniques for obtaining kidney graft: open nephrectomy, laparoscopic hand-assisted nephrectomy, and pure laparoscopic nephrectomy.

详细描述

Analytical cross-sectional study that will compare the three renal graft procurement techniques: open nephrectomy, laparoscopic hand-assisted nephrectomy, and pure laparoscopic nephrectomy. The investigators will analyze serum creatinine values on days 1, 5 and 28 post renal transplantation. The operative, medical and surgical morbidity will also be evaluated, considering the bleeding in the donor, times of ischemia and the need for JJ catheter placement in the recipient.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with terminal chronic kidney disease who will receive a kidney transplant in the transplant service of the National Medical Center of the West of living donor related to the means of obtaining the kidney graft by laparoscopic hand assisted or pure laparoscopic surgery.

排除标准

  • Patients who for some reason can not find your complete medical record.
  • Patients obtained a kidney graft from a brain death donor.

研究组 & 干预措施

Open nephrectomy

Active Comparator

These patients will undergo an open nephrectomy.

干预措施: Open nephrectomy (Procedure)

Hand-assisted laparoscopic nephrectomy

Active Comparator

These patients will undergo a hand-assisted nephrectomy.

干预措施: Hand-assisted laparoscopic nephrectomy (Procedure)

Laparoscopic nephrectomy

Active Comparator

These patients will undergo a pure laparoscopic nephrectomy.

干预措施: Laparoscopic nephrectomy (Procedure)

结局指标

主要结局

Rate of medical complications in renal graft recipients through 30 day after the nephrectomy.

时间窗: Through 30 days post surgery.

The investigators will evaluate the presence of surgical and medical complications in renal graft recipients obtained by open nephrectomy, hand assisted nephrectomy, and pure laparoscopic nephrectomy.

次要结局

  • Days of hospital stay(30 days after the nephrectomy.)
  • Bleeding during the nephrectomy(Through the nephrectomy)
  • JJ catheter placement(Perioperative (5 days post surgery))
  • Serum creatinine(Days post trasplant 1, 5 and 28.)
  • Duration of the nephrectomy in minutes(Minutes from the beginning to the end of the nephrectomy)
  • Warm ischemia time in the graft(Time in minutes between the clamping of the renal vessels and the cooling of the graft with the preservation liquid at 4º C)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Alejandro Gonzalez-Ojeda

Full time surgical researcher

Instituto Mexicano del Seguro Social

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