跳至主要内容
临床试验/NCT00592020
NCT00592020已完成不适用

"Short Transverse" Versus Conventional "Hockey Stick" Incision in Kidney Transplantation

Insel Gruppe AG, University Hospital Bern2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年1月最近更新:
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
50
试验地点
2
主要终点
QoR (Quality of Recovery) - Score

研究概览

简要总结

Today the minimal invasive access is used for a lot of different operations. This technique takes the advantage of less postoperative pain, better cosmetic results, and a lower surgical complication rate (e.g. hernia, wound infection).

Especially patients under immunosuppressive therapy could benefit from this technique. First results in minimally invasive kidney transplantation indicate that it may be performed quickly and safely. Benefits are expectable on postoperative pain, recovery, and surgical complications. Another retrospective study showed lower rates of hernia, abdominal wall relaxations, and a better postoperative cosmetic.

The aim of this study is to compare the classic hockey stick incision with a minimal invasive incision in a randomized clinical trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Age equal or over 18 years
  • Sole kidney transplantation
  • Consent form

排除标准

  • 未提供

研究组 & 干预措施

1

Active Comparator

Short Transverse Incision

干预措施: Short Transverse Incision (Procedure)

2

Active Comparator

Hockey Stick Incision

干预措施: Hockey Stick Incision (Procedure)

结局指标

主要结局

QoR (Quality of Recovery) - Score

时间窗: preoperative, day 1/3/5/7 postoperative

次要结局

  • Quality of Life by SF (Short Form) 36(preoperative, day 7, week 4, month 6 postoperative)
  • Warm ischemic time(intraoperative)
  • Operation time(intraoperative)
  • Postoperative pain measured by VAS (visual analog scale) and amount of analgesia(day 1/2/3/4/5/6/7 postoperative)
  • Surgical complications(day 7, week 4, month 6, month 12 postoperative)

研究者

申办方类型
Other

研究点 (2)

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