Assessment of the Effect of Endoscopic Sinus Surgery on Olfactory Threshold of Patients with Chronic Rhinosinusitis without Nasal Polyps; A Randomized Clinical Trial
This randomized clinical trial was conducted at Baqiyatallah University hospital, Tehran, Iran for evaluating the effect of endoscopic sinus surgery on quality of olfaction in patients with chronic rhinosinusitis.
A total of 30 patients with chronic rhinosinusitis without nasal polyps were needed for this trial. Patients between 18 and 65 years of age who had not responded to standard medical treatment with nasal irrigation by normal saline (4 times daily), nasal corticosteroid Fluticasone (one puff daily) and antibiotic therapy by Cefixime (400 mg daily) for 4 weeks, were enrolled in the trial. Patients with history of head trauma or smoking and those who were using olfaction-affecting drugs were excluded from the study. A written informed consent was obtained from all patients.
Demographic information as well as drug, trauma and smoking history were recorded in a predesigned checklist. Patients were randomly allocated to two intervention and control groups using random number table; patients in intervention group underwent endoscopic sinus surgery by a single surgeon and olfactory threshold was evaluated using smell threshold test (STT) before, one month and three months after surgery based on Pensylvania University manual. Patients in control group continued standard treatment with nasal irrigation of normal saline (4 times daily) and nasal corticosteroids (one puff daily) and olfactory threshold using STT at baseline, one and three months after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050517413N24
Registration date:2017-06-23, 1396/04/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-23, 1396/04/02
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the Effect of Endoscopic Sinus Surgery on Olfactory Threshold of Patients with Chronic Rhinosinusitis without Nasal Polyps; A Randomized Clinical Trial
Public title
The effect of endoscopic sinus surgery on improvement of olfaction in chronic rhinosinusitis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Patients between 18 and 65 years of age; no response to standard medical treatment with nasal irrigation by normal saline (4 times daily), nasal corticosteroid Fluticasone (one puff daily) and antibiotic therapy by Cefixime (400 mg daily) for 4 weeks
Exclusion criteria: Head trauma; Smoking; prior other treatments
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients were randomly allocated to two intervention and control groups using random number table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Baqiyatallah University of Medical Sciences
Street address
Nosrati ave., South Sheykh Bahaei, Mollasadra st., Vanaq sq., Tehran
City
Tehran
Postal code
Approval date
2016-04-10, 1395/01/22
Ethics committee reference number
IR.BMSU.REC.1395.10
Health conditions studied
1
Description of health condition studied
Chronic Rhinosinusitis
ICD-10 code
J31.0, J32
ICD-10 code description
Chronic Rhinitis, Chronic Sinusitis
Primary outcomes
1
Description
Olfactory threshold
Timepoint
Before, one month and three months after interventin
Method of measurement
Smell Threshold Test
Secondary outcomes
1
Description
Drug Complications
Timepoint
During study
Method of measurement
Patients' complaint
2
Description
Surgical Complications
Timepoint
After surgery
Method of measurement
Examination and patients' complaints
Intervention groups
1
Description
Intervention group: Endoscopic Sinus Surgery
Category
Treatment - Surgery
2
Description
Control group: nasal irrigation of normal saline (4 times daily) and nasal corticosteroids fluticasone (one puff daily) for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Mohammad Hossein Khosravi
Street address
Hafez, Jomhouri st., Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Baqiyatallah University of Medical Sciences
Full name of responsible person
Morteza Izadi
Street address
Baqiyatallah University of Medical Sciences, Nosrati Alley, Sheykh Bahaei st., Mollasadra st., Vanaq sq., Tehran, Iran
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Baqiyatallah University of Medical Sciences