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临床试验/NCT00184392
NCT00184392已完成不适用

Debridement After Functional Endoscopic Sinus Surgery

Norwegian University of Science and Technology4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2005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
60
试验地点
4
主要终点
Adhesions in middle meatus or not

研究概览

简要总结

The goal of this study is to increase knowledge about how to treat patients after sinus surgery.

详细描述

Many surgeons consider the postoperative treatment after sinus surgery as important for the outcome as the surgery itself. However, postoperative treatment regimes differ considerably between surgeons. They include non-intervention, frequent in-office endoscopic debridement, stenting of the middle meatus, saline douching or irrigation of the nose, or combinations of these measures in various ways. The lack of consensus is unfortunate. It indicates a lack of knowledge about how to treat these patients optimally after surgery. This is partly due to a lack of internationally acknowledged randomised, comparative, prospective studies on the effects of the various postoperative measures and their interactions. Accordingly, some patients may receive a too intensive postoperative follow up, with unnecessary frequent visits with the doctor, unnecessary bleeding and inconvenience from unnecessary debridement/cleaning of the nose, and increased costs due to unnecessary medication. Conversely, there may be patients that receive too little attention in the postoperative period, and thus may have a suboptimal result of the operation.

Frequent cleaning/debridement of the nose after sinus surgery is believed to improve the outcome of functional endoscopic sinus surgery (FESS). However, the scientific data on its effects are limited. The purpose of this study was to evaluate the effects of cleaning/ debridement of the middle meatus 5-7 days and 12-14 days after sinus surgery in a randomized, partly blinded, controlled 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 (Investigator)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Inclusion criteria are acute recurrent rhinosinusitis and chronic rhinosinusitis. The investigators used the classification of rhinosinusitis proposed by Lanza and Kennedy.

排除标准

  • Previous FESS
  • Systemic disease with affection of the nose (Wegener's granulomatosis, cystic fibrosis, Kartagener's syndrome, sarcoid)
  • Primary ciliary dyskinesia
  • Pregnancy
  • Septoplasty in the same surgery
  • Ongoing treatment for cancer

结局指标

主要结局

Adhesions in middle meatus or not

时间窗: 3 months

synechia between concha media and lateral nasal wall 0=no adhesion 1=adhesions present

次要结局

  • Pain due to cleaning of the nose(1 and 2 weeks after surgery)
  • nasal congestion after surgery(2 weeks)
  • Does cleaning of the nose reduce: crusts in the nose 14 days after surgery(2 weeks after surgery)
  • the tendency to post operative infections(3 months)
  • Does debridement increase bleeding from the nose the first 14 days after surgery(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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