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临床试验/NCT00205543
NCT00205543已完成不适用

Role of Suture Closure in Post-Operative Uvulopalatopharyngoplasty Outcomes

Virginia Commonwealth University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2004年7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
16
试验地点
2
主要终点
sleep study result at 3-6 months; symptom changes at 3-6 months; pain at 0-3 weeks; post-operative complications at any time; post-operative anatomic result/appearance at 3-6 months

研究概览

简要总结

In this study we will examine whether suture repair of the palate, or roof of mouth, has any effect on results of palate surgery performed for treatment of obstructive sleep apnea.

详细描述

Uvulopalatopharyngoplasty, or UPPP, is the most common surgical procedure performed for the treatment of obstructive sleep apnea. The procedure involves removal of redundant tissue from the lower palate (roof of mouth), including the uvula, and then suturing the cut edges of the remaining tissue together. However it is frequently noted by surgeons that sutures placed in the roof of the mouth do not stay intact. Also, in standard tonsillectomy, which involves removal of the tonsils and thus creation of a wound near the palate, no suturing is used, which does not seem to affect how the area heals. Previous studies have shown no significant differences in complication rates, post-operative pain, or symptom outcomes in patients undergoing tonsillectomy either with or without suture repair of the tonsillectomy wound. In this study we will examine whether suture repair following UPPP has any effect on post-operative pain, healing, or treatment success in terms of symptom resolution or post-operative sleep study results.

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
None

入排标准

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

入选标准

  • sleep-study documented obstructive sleep apnea
  • sleep apnea refractory to non-surgical treatments including continuous positive airway pressure (CPAP)
  • age > 21

排除标准

  • previous palate surgery

结局指标

主要结局

sleep study result at 3-6 months; symptom changes at 3-6 months; pain at 0-3 weeks; post-operative complications at any time; post-operative anatomic result/appearance at 3-6 months

时间窗: 6-12mo

次要结局

  • Operative time(immediate)
  • Procedure cost(immediate)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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