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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06612450
Enrollment
90
Registered
2024-09-25
Start date
2022-06-01
Completion date
2024-08-01
Last updated
2024-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Obstruction, Turbinate Surgery

Keywords

Turbinate Hypertrophy, Coblation, Radiofrequency, Nasal obstruction

Brief summary

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

Interventions

DEVICEturbinate surgery

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

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

only one surgeon did the surgeries, other two assessors didnt know which intervention was done, the patient didn't know which group did they belong to

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

All patients with the following criteria were eligible for inclusion: 1. Age group: 18-60 years old. 2. Patients complaining of chronic nasal obstruction because of bilateral (HIT) diagnosed by our former protocol refractory to medical treatment for at least three months. 3. 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. 4. 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

Design outcomes

Primary

MeasureTime frameDescription
NOSE score1 yearnasal obstruction symptom score for subjective analysis of patient symptom before and after intervention
Pain VAS score1-3 months postoperativepatient score on a scale from 0 to 10 where 0 is no pain and 10 is most severe pain
Turbinate Size grading1 year postoperativeendoscopic grading of turbinate size before and after intervention from 0-4 where 1 is 25% of nasal cavity

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026