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临床试验/NCT02547090
NCT02547090已完成不适用

The Effect of Two Surgeons on Blood Loss and Operative Time in Cerebral Palsy (CP) Patients Undergoing Posterior Spinal Fusion

Phoenix Children's Hospital0 个研究点目标入组 50 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
主要终点
Complications due to PFS surgery

研究概览

简要总结

Background:

Posterior spinal fusion (PSF) in children with cerebral palsy (CP) carries a high risk of complications and mortality. Complication rates have been reported as high as 45%, and infection rates typically reported at 15%. Efforts to improve efficiency by reducing operative time and blood loss could decrease these risks. The purpose of this study is to investigate the impact of utilizing two attending surgeons on blood loss, operative time, and complications in this population.

Methods:

This is a prospective, matched cohort analysis with a consecutive series of patients with CP who underwent PSF, with two attending surgeons, in 2012. These are matched with a control group that had a single-surgeon team (operative dates 2008-2010), assisted by a resident, PA, or RN-FA. The groups are compared using paired Student T-tests and chi square tests (significance set a p<0.05).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • Cerebral palsy
  • neuromuscular scoliosis requiring posterior spinal fusion (>50 degree Cobb)
  • PSF from 2008-2012 at Phoenix Children's Hospital
  • GMFCS IV or V

排除标准

  • Diagnosis other than CP
  • GMFCS I-III
  • Previous spine deformity surgery

结局指标

主要结局

Complications due to PFS surgery

时间窗: Post-operative hospital stay (up to 12 days)

次要结局

  • Surgical time(intraoperative)
  • Estimated blood loss(intraoperative)
  • Length of Stay(During hospitalization (up to 12 days))

研究者

申办方类型
Other
责任方
Sponsor

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