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临床试验/NCT01852643
NCT01852643已完成2 期

Determine and Compare the Finding of Rhinomanometry Before and After Treatment in Two Ways of Rhinoplasty Surgery (Spreader Graft and Lateral Crural Over Lapping)

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Nasal flow

研究概览

简要总结

Most of the studies performed to compare the present techniques of rhinoplasty have been based on the clinical examination and change of postoperative complaints that cannot be very precise in evaluating the advantages of one technique over another. Therefore, in this study the investigators are going to compare the efficacy of spreader graft and lateral crural overlay techniques by an objective method, rhinomanometry.

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
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Candidates of rhinoplasty
  • Willingness to participate

排除标准

  • Having structural problems such as nasal obstruction
  • History of the deformity requiring rhinoplasty of the deviated septum
  • Hardening surgery
  • New clinical conditions or a change in therapeutic technique
  • Unwillingness to continue participating in the study
  • Having no access to subjects after the operation

结局指标

主要结局

Nasal flow

时间窗: Up to 3 months

Rhinomanometry is performed by a technician in two stages: before surgery and three months after surgery. It is performed in line with the standards suggested by the "Committee Report on Standardization of Rhinomanometry". After surgery, patients are monitored for one month and rhinomanometry is performed under the same initial conditions after three months. In both stages of rhinomanometry, nasal resistance means are evaluated by Pascal per milliliter per second (Pa/mL/s) and the right and left and total nasal flow indices are evaluated by milliliter per second (mL/s).

Nasal resistance

时间窗: Up to 3 months

Rhinomanometry is performed by a technician in two stages: before surgery and three months after surgery. It is performed in line with the standards suggested by the "Committee Report on Standardization of Rhinomanometry". After surgery, patients are monitored for one month and rhinomanometry is performed under the same initial conditions after three months. In both stages of rhinomanometry, nasal resistance means are evaluated by Pascal per milliliter per second (Pa/mL/s) and the right and left and total nasal flow indices are evaluated by milliliter per second (mL/s).

次要结局

未报告次要终点

研究者

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

Dr. Amiryousef Ahmadnia

Dr.

Isfahan University of Medical Sciences

研究点 (1)

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