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Clinical Trials/CTRI/2020/01/022725
CTRI/2020/01/022725Active, not recruitingNot Applicable

Comparison of the effiacy of endoscopic and conventional techniques of septoturbinoplasty

Ishan Sardesai1 site in 1 country56 target enrollmentStarted: January 14, 2020Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
56
Locations
1
Primary Endpoint
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.

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 80.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

  • % 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))

Investigators

Sponsor
Ishan Sardesai
Sponsor Class
Other [Self ]

Study Sites (1)

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