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临床试验/NCT07832916
NCT07832916尚未招募不适用

Comparison Between Turbinoplasty Techniques in Chronic Nasal Obstruction Microdebrider Coblation andSubmucosalBipolarDiathermyTechniquesduetohypertrophoidturbinate

Assiut University0 个研究点目标入组 66 人开始时间: 2026年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
66
主要终点
Change in endoscopic inferior turbinate grade

研究概览

简要总结

Chronic nasal obstruction is one of the most common complaints in otorhinolaryngology practice, with inferior turbinate hypertrophy being a major anatomical cause that significantly impairs nasal airflow and quality of life.(1) It is commonly associated with allergic rhinitis, vasomotor rhinitis, chronic rhinosinusitis, and compensatory hypertrophy secondary to septal deviation. (2) When medical treatment fails, surgical reduction of the inferior turbinate becomes necessary.(2) Available techniques include Microdebrider (3) , Coblation(4), and Submucosal Bipolar Diathermy(5) aim to reduce turbinate volume while maintaining normal mucosal function and are associated with less tissue damage than conventional procedures. (6) Although several surgical techniques have shown good clinical outcomes, no single method has been established as the gold standard. Comparative evidence evaluating microdebrider, coblation, and bipolar in the same prospective study remains limited,(7) particularly in the Egyptian population.

Therefore, this study aims to compare these techniques regarding efficacy, safety, postoperative outcomes, and patient satisfaction to provide evidence that supports appropriate surgical decision-making

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18- 60 years of either sex.
  • Chronic nasal obstruction of more than 3 months' duration attributable to bilateral inferior turbinate hypertrophy (Grade II or III on endoscopic grading).

排除标准

  • Nasal obstruction primarily attributable to severe septal deviation requiring septoplasty as the main corrective procedure.
  • Chronic rhinosinusitis with nasal polyposis.
  • Nasal or paranasal sinus tumors/masses.
  • Previous nasal, turbinate, or sinus surgery.
  • Atrophic rhinitis or empty nose syndrome.
  • Uncontrolled bleeding disorders or use of anticoagulant/antiplatelet therapy that cannot be safely withheld.
  • Uncontrolled systemic disease (e.g., uncontrolled diabetes mellitus, hypertension) precluding surgery/anesthesia.
  • Pregnancy.
  • Active nasal infection at the time of surgery.
  • Patient refusal to participate or to complete follow-up.

研究组 & 干预措施

Group A

Active Comparator

Microdebrider-Assisted Turbinoplasty

干预措施: Microdebrider-Assisted Turbinoplasty (Procedure)

Group B

Active Comparator

Coblation-Assisted Turbinoplasty

干预措施: Coblation-Assisted Turbinoplasty (Procedure)

Group c

Active Comparator

Submucosal Bipolar Diathermy Assisted Turbinoplasty

干预措施: Submucosal Bipolar Diathermy Assisted Turbinoplasty (Procedure)

结局指标

主要结局

Change in endoscopic inferior turbinate grade

时间窗: 6 months

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

Mary Zakaria Fam Sedhom

residant doctor at Assiut university hospital

Assiut University

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