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

Not Applicable

Completed

• Conditions: Nasal Obstruction; Turbinate Surgery
• Interventions: Device: turbinate surgery

• Registration Number: NCT06612450
• Lead Sponsor: Kafrelsheikh University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-08-01
• Status Verified: 2024-09
• Study First Submitted: 2024-09-21
• Study First Submitted QC: 2024-09-24
• Last Update Submitted: 2024-09-24
• Study First Posted: 2024-09-25
• Last Update Posted: 2024-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Coblation	turbinate surgery	patients will undergo turbinoplasty using coblation wand
RaVoR	turbinate surgery	patients will undergo turbinate reduction using ravor radiofrequency

Primary Outcome Measures

Name	Time	Method
NOSE score	1 year	nasal obstruction symptom score for subjective analysis of patient symptom before and after intervention
Pain VAS score	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	1 year postoperative	endoscopic grading of turbinate size before and after intervention from 0-4 where 1 is 25% of nasal cavity

Trial Locations

Locations (1)

Kafr El-Sheikh Universitty; 🇪🇬 Kafr El-sheikh, Egypt