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临床试验/NCT02658318
NCT02658318已完成不适用

Postoperative Complications After Cleft Palate Closure in Patients With Pierre Robin Sequence: Operative Considerations

AZ Sint-Jan AV1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2011年1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
92
试验地点
1
主要终点
Incidence of peri- and postoperative complications

研究概览

简要总结

In cleft surgery there is no current general agreement on the treatment strategy of patients with the Pierre Robin Sequence. The timing of surgery and the surgical approach depends on the treating physician or the hospital facility. Literature regarding peri- and postoperative complications in the target population are lacking.

The investigators aim to retrospectively review the charts of all cleft patients, both PRS and non-PRS, treated with an adapted Furlow palatoplasty between 01/01/2011 and 31/08/2015. The incidence of peri- and postoperative complications, with a specific focus on respiratory complications, will be examined. The value of demographic, surgical and postoperative parameters will be examined as potential risk factors for the development of complications.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • patients of all ages
  • patients that had undergone a modified Furlow palatoplasty
  • patients treated at the GH Saint-John Bruges (Belgium), or the cooperating Semmelweis University (Hungary)

排除标准

  • patients not eligible according to the abovementioned criteria

结局指标

主要结局

Incidence of peri- and postoperative complications

时间窗: within 4 weeks postoperative

次要结局

  • Identification of potential risk factors (demographic, diagnostic, surgical) for development of postoperative complications, through regression analysis(within 4 weeks postoperative)

研究者

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

Johan Abeloos

Maxillofacial surgeon, Head of Department

AZ Sint-Jan AV

研究点 (1)

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