Comparison between 2 different techniques of performing deviated nasal septum correction surgery

Active, not recruiting

• Conditions: Deviated nasal septum,

• Registration Number: CTRI/2020/01/022725
• Lead Sponsor: Ishan Sardesai

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-14
• Last Update Posted: 2021-11-28

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
% 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)

Trial Locations

Locations (1)

Kasturba Medical College; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Medical College

🇮🇳Udupi, KARNATAKA, India

Ishan Sardesai

Principal investigator

ishansardesai@hotmail.com