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临床试验/CTRI/2024/07/070796
CTRI/2024/07/070796招募中不适用

Efficacy of balloon sinuplasty versus endoscopic sinus surgery for chronic rhinosinusitis without nasal polyposis A non randomized controlled trial

Uttar Pradesh university of medical Sceinces Saifai Etawah1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年7月27日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
46
试验地点
1
主要终点
efficacy of balloon sinuplasty in comparison to endoscopic sinus surgery for CRS without nasal polyposis in term of Sucess rate.

研究概览

简要总结

title of this study was A non Randomized controlled trial ,of  Efficacy of balloon sinuplasty versus endoscopic sinus surgery for chronic rhinosinusitis without nasal polyposis.

This study will be conducted in department of ENT at UPUMS Saifai, aiming to enroll 46 eligible patients age 15-60 years with CRS without nasal polyposis .Pt. selected on the basis  of inclusion and exclusion criteria .

Data will be collected through comprehensive pre operative  assessments , intra operative , records and post operative follow up at 1 week , 3 months, and  6 months.

Aim of this study is compare Efficacy of balloon sinuplasty versus endoscopic sinus surgery for chronic rhinosinusitis without nasal polyposis.

Objective of this study determine -to determine the efficacy of balloon sinuplasty in compression to endoscopic sinus surgery for chronic rhinosinusitis without nasal polyposis in term of Sucess rate.

To compare the symptoms relief in patients , using SNOT 22 scoring

expected outcome Balloon sinuplasty is minimally invasive procedure

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
15.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Diagnosed with chronic rhinosinusitis without nasal polyposis based on clinical and radiological criteria.
  • Unilateral or bilateral maxillary chronic rhinosinusitis which had been unresponsive to 3 weeks of medical management.
  • Willingness to undergo either Balloon sinuplasty or Endoscopic sinus surgery based on clinical assessment and shared decision making.

排除标准

  • Patients with chronic rhinosinusitis with nasal polyposis.
  • Isolated ethmoidal or infundibular disease.
  • Patients with contraindications to either Balloon sinuplasty or endoscopic sinus surgery.
  • Associated condition like ciliary dysmotility syndrome, mucopolysaccharidosis or cystic fibrosis.
  • Presence of distorted osteo-meatal unit anatomy.
  • Allergic fungal rhinosinusitis.
  • Revision surgery.

结局指标

主要结局

efficacy of balloon sinuplasty in comparison to endoscopic sinus surgery for CRS without nasal polyposis in term of Sucess rate.

时间窗: efficacy of balloon sinuplasty in comparison to endoscopic sinus surgery for CRS without nasal polyposis in term of Sucess rate. | Check by regular follow up at interval of 1 week,3months and 6 months

次要结局

  • To compare the relief in patient symptomsusing SNOT-22 between two study groups.(Assess the results BSP and ESS by LUND KENNEDY SCORE.)

研究者

发起方
Uttar Pradesh university of medical Sceinces Saifai Etawah
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Virendra Kumar

Uttar Pradesh University Of Medical Sciences ,Saifai Etawah U.P

研究点 (1)

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