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

K

Kafrelsheikh University

Status

Completed

Conditions

Nasal Obstruction
Turbinate Surgery

Treatments

Device: turbinate surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT06612450
MKSU200-289

Details and patient eligibility

About

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

Enrollment

90 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

90 participants in 2 patient groups

Coblation
Active Comparator group
Description:
patients will undergo turbinoplasty using coblation wand
Treatment:
Device: turbinate surgery
RaVoR
Active Comparator group
Description:
patients will undergo turbinate reduction using ravor radiofrequency
Treatment:
Device: turbinate surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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