A study of outcome and Quality of Life assessment in patients with chronic allergy after nasal irrigation using normal saline with budesonide after endoscopic nose surgery

Not yet recruiting

• Conditions: Chronic pansinusitis,

• Registration Number: CTRI/2019/02/017402
• Lead Sponsor: JLN MEDICAL COLLEGE

Brief Summary

Aim: The study is planned toevaluate postoperative nasal irrigation practices and the compliance ofpatients after FESS. Short-term outcomes in post-FESS patients using nasalsaline with steroid will be assessed.

Primary objective:

1.      Toassess the compliance and factor affecting compliance of patients for nasalsaline irrigation after Functional Endoscopic Sinus Surgery.

2.      Assessmentand comparison of changes in QoL based on the 22-item Sinonasal Outcomes Test(SNOT-22) after functional endoscopic sinus surgery with topical nasal steroidsand normal saline irrigation.

3.      Assessmentand comparison of changes in endoscopic finding using Lund-Kennedy Endoscopyscore after functional endoscopic sinus surgery with topical nasal steroids andnormal saline irrigation.

Secondary Objective:

                 1. To assess significantand local adverse effect of nasal irrigation and their impact on compliance ofnasal irrigation.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-01-02
• Study Start: 2019-03-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Chronic rhinosinusitis diagnosed according to European position paper on rhinosinusitis and nasal polyps EPOS 2012.
• Characteristic changes in pre-operative computed tomography of paranasal sinuses assessed according to EPOS 2012.
• Chronic rhinosinusitis patients with bilateral nasal polyps who had not improved after medical treatment.
• Chronic rhinosinusitis patients without nasal polyps who had not improved after medical treatment.

Exclusion Criteria

• • Other subgroups of CRS; Secondary CRS.
• •Age under 18 years.
• •Pregnancy.
• •Immunodeficiency.
• •Patients who are undergoing revision endoscopic sinus surgery.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate postoperative nasal irrigation practices and the compliance of patients after FESS. Short-term outcomes in post-FESS patients using nasal saline with steroid will be assessed.	Duration of study is around one year.

Secondary Outcome Measures

Name	Time	Method
To evaluate postoperative nasal irrigation practices and the compliance of patients after FESS. Short-term outcomes in post-FESS patients using nasal saline with steroid will be assessed.	Duration of study is around one year.

Trial Locations

Locations (1)

JLN MEDICAL COLLEGE; 🇮🇳 Ajmer, RAJASTHAN, India

JLN MEDICAL COLLEGE

🇮🇳Ajmer, RAJASTHAN, India

DR GIRIRAJ PRASAD TRIVEDI

Principal investigator

8824176231

gptparul007@gmail.com