To compare the impact of microdebrider assisted inferior turbinoplasty vs inferior turbinate cauterization on the quality of life of children.
Design
A randomized double-blind clinical trial study with a control group, with parallel design on 54 patients. Block randomization method will be used for randomization.
Settings and conduct
Shahid Dastgheib hospital affiliated to Shiraz University of Medical Sciences
Participants/Inclusion and exclusion criteria
Patients under 18 years of age with inferior turbinate hypertrophy who complained of nasal congestion and rhinorrhea in rhinoscopy and did not respond well to oral or topical corticosteroids, antihistamines, and other conservative methods, who were candidate for turbinate reduction surgery included in this study.
To compare the impact of microdebrider assisted inferior turbinoplasty vs inferior turbinate cauterization on the quality of life of children
Public title
To compare the impact of microdebrider assisted inferior turbinoplasty vs inferior turbinate cauterization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
inferior turbinate hypertrophy
nasal congestion
Existence of rhinorrhea
Failure to respond to medications including oral or topical corticosteroids, antihistamines
Exclusion criteria:
Age more than 18 years
Adenoid hypertrophy
Nasal polyps
Severe deviation of the nasal septum
Age
To 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
27
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to microذeprider assisted inferior turbinoplasty (number 0 in select case) or inferior turbinate cauterization (number 1 in select case) groups (1: 1 ratio) using random numbers which were generated through computerized block randomization using SPSS software version 23. To reduce selection bias and confounding factors, randomization was performed by a single appointed researcher who did not participate in data collection.
Blinding (investigator's opinion)
Double blinded
Blinding description
patients, outcome assessor, and statisticians who analyzed the data were unaware of the intervention and allocation of treatments until the statistical analysis was complete.
What processes are involved for a request to access data/document
the request should be sent by email (containing personal and professional information), describing their study protocol, after approving their identity and proposal, the data will be sent by email.