跳至主要内容
临床试验/CTRI/2020/01/022725
CTRI/2020/01/022725进行中(未招募)不适用

Comparison of the effiacy of endoscopic and conventional techniques of septoturbinoplasty

Ishan Sardesai1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2020年1月14日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
56
试验地点
1
主要终点
Improvement of nasal symptoms following septoturbinoplasty based on subjective NOSE questionnaire data collected pre and post operatively and data collected through diagnostic nasal endoscopy, pre and post operatively, analysed using Lund-Kennedy scoring system.

研究概览

简要总结

This is a prospective, observational cohort study in which efficacy of endoscopic and conventional techniques of septoturbinoplasty will be compared. This will be done using subjective data through administration of NOSE questionnaire to patients pre and post operatively as well as objective data through diagnostic nasal endoscopy. Total study period is 2 years. The study includes patients fulfilling criteria for patient selection. The type of surgery will be decided by the treating surgeon. The surgical procedure as well as investigations are as per standard care of treatment. Follow up visits for each patient is at 1 and 3 months as per standard care of treatment and not for sake of the study. Results will be analyzed using appropriate statistical methods.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with symptomatic deviated nasal septum, anterior as well as posterior deviation of septum, with no radiographic evidence of sinusitis, with associated allergic rhinitis adequately controlled by medical management, with associated turbinate hypertrophy.

排除标准

  • Patients below 18 years of age, patients with mild asymptomatic deviated nasal septum, with sinus disease involving 2 or more paranasal sinuses, with radiographic evidence of sinusitis, with caudal dislocation of septum, undergoing revision surgery, with vasomotor rhinitis and nasal polyps, with allergic rhinitis not adequately controlled by medical management, those undergoing septorhinoplasty.

结局指标

主要结局

Improvement of nasal symptoms following septoturbinoplasty based on subjective NOSE questionnaire data collected pre and post operatively and data collected through diagnostic nasal endoscopy, pre and post operatively, analysed using Lund-Kennedy scoring system.

时间窗: Follow up period of each study subject will be 1 and 3 months (as per standard of care).

次要结局

  • % of intraoperative and postoperative complications in endoscopic versus conventional septoturbinoplasty groups(Follow up period of each study subject will be 1 and 3 months (as per standard of care))

研究者

发起方
Ishan Sardesai
申办方类型
Other [Self ]

研究点 (1)

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