Turbinate Volume Reduction Under Local Anesthesia: Randomized Clinical Trial; Our Experience

The purpose of this trial is to know which method is better in delivering radiofrequency waves for hypertrophied turbinates: coblation or RavoR technique? Researchers will compare both techniques in randomized blinded manner patients will have subjective outcomes like NOSE score, pain Objective outcomes like Turbinate size over long term clinical follow up visits for 1 year

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Key information

Conditions

Nasal Obstruction Airway Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Turbinate Surgery

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafr El-Sheikh Universitty

Kafr ash Shaykh, Kafr el-Sheikh Governorate, 6850001, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients with the following criteria were eligible for inclusion:

Age group: 18-60 years old.
Patients complaining of chronic nasal obstruction because of bilateral (HIT) diagnosed by our former protocol refractory to medical treatment for at least three months.
Evident (HIT) on the CT nose and paranasal sinuses with mainly soft tissue component hypertrophy with or without minimal septal deviation without any other cause for the obstruction.
Patients who are unfit for general anesthesia

Exclusion criteria

All Patients with:

Marked septal deviation or Concha Bullosa, Nasal polyps, Sinonasal Tumors, Any previous nasal surgeries or radiotherapy, Chronic sinusitis or Cystic Fibrosis, Pregnancy, Patients with severe bleeding tendency, coagulopathy disorder, and Patients who refuse participation in this study were excluded from our study

Treatment and study plan

turbinate surgery

Device

Turbinoplasty to decrease the turbinate size in cases with turbinate hypertrophy with mainly soft tissue component without sacrificing the mucosal function

Primary outcomes

NOSE score

Time frame: 1 year

nasal obstruction symptom score for subjective analysis of patient symptom before and after intervention
Pain VAS score

Time frame: 1-3 months postoperative

patient score on a scale from 0 to 10 where 0 is no pain and 10 is most severe pain
Turbinate Size grading

Time frame: 1 year postoperative

endoscopic grading of turbinate size before and after intervention from 0-4 where 1 is 25% of nasal cavity

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Sep 25, 2024
Registry last updated: Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed